CURRICULUM VITAE

DAVID J KIRKLAND

PERSONAL DETAILS

Name KIRKLAND David John

Date of Birth 18 June 1949

Education

1967-1970 University of London

BSc Honours in Microbiology

Upper Second Class

1970-1973 Imperial Cancer Research Fund, London

Post-graduate research into the in vitro interactions of viral and

chemical carcinogens. PhD awarded by Brunel University

PRESENT EOMPLOYMENT

2009-present Kirkland Consulting

Independent genetic toxicology consultant.

PREVIOUS EMPLOYMENT

1997 - 2009 Covance Laboratories Europe (CLE)

Vice President of Scientific and Regulatory Consulting: responsible

for the pharmaceutical regulatory affairs group and expert reviews

(consultancy). This includes developing and promoting the regulatory

and scientific expertise within CLE to “add value” to client projects.

1992- 1997 Hazleton Europe (Corning Hazleton, Covance)

Director (subsequently Vice President) of Toxicology: responsible for

the mammalian, molecular and cellular toxicology groups (study

directors and operations staff) including planning, costing, GLP

compliance, scientific interpretation, health and safety.

1990-1992 Hazleton Microtest

Head of Molecular Toxicology: overall responsibility for all the

programmes of molecular toxicology for all clients. This included

client liaison, planning, costing, GLP compliance and scientific

interpretation, including regulatory requirements.

Dr David J Kirkland

Curriculum Vitae

Page 2

1984-1990 Microtest Research Limited

Director of Molecular Toxicology: overall responsibility for all the

programmes of molecular toxicology for all clients. This included

client liaison, planning, costing, GLP compliance and scientific

interpretation, including regulatory requirements.

1979-1984 Toxicol Laboratories Limited

Research Director: responsible for managing sections providing

chemistry, biochemistry, microbiology and genetic toxicology services,

including being Head of Genetic Toxicology for the company.

1976-1979 Chester Beatty Research Institute

Post-doctoral Fellow: two projects were undertaken, namely the

cytogenetic monitoring of the circulating lymphocytes and bone

marrow of Polycythaemia Rubra Vera patients on different forms of

treatment, and investigations of cytogenetic abnormalities in humans

exposed occupationally or as consumers to hair dyes.

1973-1976 Post-doctoral Fellow: projects to develop an in vitro mammalian cell

malignant transformation system in Chinese hamster cells maintained

in a diploid state by special culture techniques, and to investigate

cytotoxicity and chromosomal damage induced by hair dyes.

PROFESSIONAL SOCIETIES

1977-Present UK Environmental Mutagen Society

1977-Present European Environmental Mutagen Society

1982-Present Environmental Mutagen Society USA

1970-1994 British Association for Cancer Research

1988-Present Genetic Toxicology Association USA

1989-2010 British Toxicology Society

1986-2010 Institute of Biology

Dr David J Kirkland

Curriculum Vitae

Page 3

RECOGNITION AND AWARDS

Fellow of the UK Environmental Mutagen Society (2002)

Honorary Professor of the University of Wales, Swansea (2006-present)

First recipient of the Industrial Genotoxicity Group (UKEMS) Distinguished Toxicologist

Award (2010)

Recipient of the US Environmental Mutagen Society Alexander Hollaender Award for

scientific contributions to the field of genetic toxicology and for global leadership in the

regulation of toxicology testing (2010).

PROFESSIONAL ACTIVITIES

Member, UK Government Advisory Committee on Mutagenicity (2009-present)

Chairman, Industry and Regulatory Special Interest Group, European Environmental Mutagen

Society, (2000-present)

President of UK Environmental Mutagen Society (1992 - 1994)

President of European Environmental Mutagen Society (2009-2011)

Mutagenesis Editorial Board Member (1992 - 2004)

Special Issues Editor, Mutation Research,(Genetic Toxicology and Environmental

Mutagenesis section (2005-present)

Mutation Research Editorial Board Member (Genetic Toxicology Testing Section)

(1990 - 2004)

Editor UK Environmental Mutagen Society Guidelines Reports (1986 - 1990)

Toxicology Advisory Panel Member for the Cosmetics, Toiletries and Perfumeries

Association (1980 - 1984)

Local Organiser of 12th Annual UK Environmental Mutagen Society meeting, York 1988

Local Organiser of 20th European Environmental Mutagen Society meeting, York 1990

Organiser of "International Workshops on Standardisation of Genotoxicity Test Procedures",

Melbourne, Australia 1993 and Washington D.C., 1999.

Chair of Peer Consultation Workshop on Genotoxicity for Categorization of “Inherent

Toxicity” to Humans under the Canadian Environmental Protection Act (CEPA ’99), co-

sponsored by International Life Sciences Institute and Health Canada, Ottawa, Canada, 2002.

Dr David J Kirkland

Curriculum Vitae

Page 4

Organiser of the 3rd

, 4th

and 5th

International Workshops on Genotoxicity Tests (Plymouth,

Devon, England, 2002; San Francisco, California, USA, 2005; Basel, Switzerland, 2009) and

co-organiser of the 6th

IWGT (Foz do Iguacu, Brazil, 2013)..

SCIENTIFIC PUBLICATIONS

Kirkland D J and Pick C R (1973). The histological appearance of tumours derived from rat

embryo cells transformed in vitro spontaneously and after treatment with nitrosomethylurea.

Brit J Cancer 28:440-452.

Kirkland D J, Armstrong C & Harris R J C (1975). Spontaneous and chemically induced

transformation of rat embryo cell cultures. Brit J Cancer 31:329-337.

Kirkland D J & Venitt S (1976). Cytotoxicity of hair colourant constituents: chromosome

damage induced by two nitrophenylenediamines in cultured Chinese hamster cells. Mutat

Res 40:47-56.

Kirkland D J (1976). Chemical transformation of Chinese hamster cells. I A comparison of

some properties of transformed cells. Brit J Cancer 34:134-144.

Kirkland D J & Venitt S (1976). Chemical transformation of Chinese hamster cells. II

Appearance of marker chromosomes in transformed cells. Brit J Cancer 34:145-152.

Roberts J J, Friedlos F, Van Den Berg H W & Kirkland D J (1977). Inhibition by caffeine

of post-replication repair in Chinese hamster cells treated with

7-bromomethylbenz-(a)-anthracene. Enhancement of toxicity, chromosome damage and

inhibition of ligation of newly-synthesised DNA. Chem Biol Interactions 17:265-290.

Kirkland D J, Lawler S D & Venitt S (1978). Chromosomal damage and hair dyes.

Lancet ii:124-128.

Kirkland D J (1979). Hair dye genotoxicity. American Heart Journal 98:814.

Kirkland D J, Welch S J, Povey S, Najfeld V, Price D J & Lawler S D (1980). Glutamic

pyruvate transaminase phenotypes in Polycythaemia Rubra Vera.

Ann Hum Genetics 44:407-413.

Kirkland D J, Smith K L & Van Abbe N J (1981). Failure of chloroform to induce

chromosome damage or sister chromatid exchanges in cultured lymphocytes and failure to

induce reversion in E coli. Fd Cosmet Toxicol 19:651-656.

Kirkland D J, Honeycombe J R, Lawler S D, Venitt S & Crofton-Sleigh C (1981). Sister

chromatid exchanges before and after hair dyeing. Mutat Res 90:279-286.

Kirkland D J, Smith K L & Parmar V (1982). Bacterial mutagenicity tests on

4-chloromethyl biphenyl and two structural analogues. Mutat Res 100:21-25.

Dr David J Kirkland

Curriculum Vitae

Page 5

Kirkland D J, Smith K L & Jenkinson P C (1982). Metaphase analysis of human

lymphocytes treated with 4-chloromethyl biphenyl and benzyl chloride.

Mutat Res 100:297-299.

Kirkland D J, Jenkinson P C & Smith K L (1982). Sister chromatid exchanges in human

lymphocytes treated with 4-chloromethyl biphenyl and benzyl chloride.

Mutat Res 100:301-304.

Kirkland D J (1982). Cytogenetic monitoring of human populations. In M Balls,

R J Riddell & A N Warden, ed. Animals and Alternatives in Toxicity Testing.

Academic Press, London, pp 409-414.

Kirkland D J (1983). The mutagenicity and carcinogenicity of hair dyes. A review.

Int J Cosmet Sci 5:51-71.

Kirkland D J, Creed K L & Mannisto P (1983). Comparative bacterial mutagenicity studies

with 8-methoxypsoralen and 4,5',8-trimethylpsoralen in the presence of near ultra violet light

and in the dark. Mutat Res 116:73-82.

Scott D, Danford N, Dean B, Kirkland D & Richardson C (1983). In vitro chromosome

aberration assays. In B Dean, ed. UKEMS Subcommittee on Guidelines for Mutagenicity

Testing, Report, Part I, Basic Test Battery. United Kingdom Environmental Mutagen

Society, Swansea, pp 41-64.

Perry P, Henderson L & Kirkland D (1984). Sister chromatid exchange in cultured cells. In

B Dean, ed. UKEMS Sub-committee on Guidelines for Mutagenicity Testing, Report, Part II,

Supplementary Tests. United Kingdom Environmental Mutagen Society, Swansea, pp 89-

121.

Kirkland D, Gatehouse D, Sullman S, Venitt S, Watkins P, Reed P & Walters C (1984).

Bacterial mutation assays with nitrosation products. In B Dean, ed. UKEMS Sub-committee

on Guidelines for Mutagenicity Testing, Report, Part II, Supplementary Tests. United

Kingdom Environmental Mutagen Society, Swansea, pp 245-260.

Varley R B, Rae J D & Kirkland D J (1985). A comparison of the effects of uninduced

mouse, uninduced rat and Aroclor-induced rat liver S-9 on reversion in Salmonella by DAB

and CDA. In J M Parry & C F Arlett, ed. Comparative Genetic Toxicology. Macmillan Press

Limited, Basingstoke & London, pp 89-92.

Asquith J C, Hogan L K, Fullwood J N, Rae J D & Kirkland D J (1985). A comparison of

the chromosome damaging effects, in cultured human lymphocytes, of benzidine (BZD) and

4,4'-diaminoterphenyl (DAT) in the presence of Aroclor-induced and uninduced rat liver S-9.

In J M Parry & C F Arlett, ed. Comparative Genetic Toxicology. Macmillan Press Limited,

Basingstoke & London, pp 355-362.

Mannisto P T, Kirkland D J, Viluksela M & Tikkanen L (1986). Toxicological studies with

dithranol and its 10-acyl analogues. Arch Toxicol 59:180-185.

Dr David J Kirkland

Curriculum Vitae

Page 6

Garner R C & Kirkland D J (1986). Letter to the editor. Mutagenesis 1:233-235.

Kirkland D J (1986). Alternatives to animal tests for detecting carcinogens and mutagens.

Biologist 33:79-82.

Kirkland D J 1987). Implications of germ cell cytogenetic tests in the regulatory process.

Mutagenesis 2:61-67.

Garner R C, Campbell J, Kirkland D J & Kennelly J C (1987). Use of 6TG-resistance in

wild type mouse lymphoma L5178Y cells for gene-mutagen screening. Environ Mutagenesis

9 Suppl 8:38 (abstract).

Kirkland D J & Garner R C (1987). Current issues in Mutagenesis and Carcinogenesis. No

8. Testing for genotoxicity - chromosomal aberrations in vitro - CHO cells or human

lymphocytes? Mutat Res 189:186-187.

Kirkland D J (1989). Mammalian cells in culture. Report of a participant workshop. Mutat

Res 213:41-42.

Kirkland D J, Marshall R R, McEnaney S, Bidgood J, Rutter A & Mullineux S (1989).

Aroclor-1254 induced rat liver S-9 causes chromosomal aberrations in CHO cells, but not

human lymphocytes: A role for active oxygen? Mutat Res 214:115-122.

D J Kirkland, ed. Statistical evaluation of mutagenicity test data. Cambridge University

Press, Cambridge - New York - Port Chester - Melbourne - Sydney (1989).

Scott D, Danford N, Dean B & Kirkland D (1990). Metaphase chromosome aberration

assays in vitro. In D J Kirkland, ed. Basic mutagenicity tests: UKEMS recommended

procedures. Cambridge University Press, Cambridge - New York - Port Chester - Melbourne

- Sydney, pp 62-86.

D J Kirkland (1990). Selection of Mutagenicity and Cell Transformation Tests -

Interpretation of Results. In A Sundwall et al, eds. Preclinical Evaluation of Peptides and

Recombinant Proteins. (Excerpts from a workshop). Skogs Grafiska AB, Malmo, pp 49-56.

Dean S W, Lane M, Dunmore R H, Ruddock S P, Martin C N, Kirkland D J and Loprieno N

(1991). Development of assays for the detection of photomutagenicity of chemicals during

exposure to UV light - I. Assay development. Mutagenesis 6:335-342.

Clare C B, Ballantyne M, Kirkland D J, Pickering S and Robinson D G (1991). Effects of

alterations in the composition of the S-9 mix on the spontaneous mutation frequencies of

some bacterial test strains. Mutagenesis 6:427 (abstract).

McEnaney S, Marshall R R, Campbell J, Riley S, Hudson L and Kirkland D J (1991). The

clastogenic effects of non-physiological pH on human lymphocytes in whole blood and

Chinese hamster ovary cells, in vitro, following pulse and continuous exposure. Mutagenesis

6:444 (abstract).

Dr David J Kirkland

Curriculum Vitae

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Clements J, Fellows M D, Oxley P A, Doran A, Clare C B and Kirkland D J (1991). A

validation exercise for the TK assay in mouse lymphoma L5178Y cells using a Microtitre®

fluctuation protocol. Mutagenesis 6:444 (abstract).

Kirkland D J (1992). Chromosomal aberration tests in vitro: problems with protocol design

and interpretation of results. Mutagenesis 7:95-106.

Kirkland D J, Dresp J H, Marshall R R, Baumeister M, Gerloff C and Gocke E (1992).

Normal chromosomal aberration frequencies in peripheral lymphocytes of healthy human

volunteers exposed to a maximum daily dose of paracetamol in a double blind trial. Mutat

Res 279:181-194.

Dean S W, Dunmore R H, Ruddock S P, Dean J C, Martin C N and Kirkland D J (1992).

Development of assays for the detection of photo-mutagenicity of chemicals during exposure

to UV-light. II. Results of testing 3 sunscreen ingredients.

Mutagenesis 7:179-182.

Fielder R J, Allen J A, Boobis A R, Botham P A, Doe J, Esdaile D J, Gatehouse D G,

Hodson-Walker G, Morton D B, Kirkland D J and Richold M (1992). Dose setting in vivo

mutagenicity assays. Report of a BTS/UKEMS Working Party.

Mutagenesis 7:313-319.

Kirkland D J (1993). Genetic toxicology testing requirements: Official and unofficial views

from Europe. Envir Mol Mutag 21, 8-14.

Shibahara T, Kaneko E, Itoh T, Awogi T, Tsushimoto G, Takahashi N, Marshall R R and

Kirkland D J (1993). Mutagenic and clastogenic properties of BOF-A2, a new

5-fluorouracil derivative with anti-tumour activity. J Tox Sci 18 (Suppl III), 11-19.

Kirkland D J (1993). The need for international standardisation of genotoxicity test

procedures. In "International Workshop on Standardisation of Procedures in Genetic

Toxicology", Ed T Sofuni, Scientist Inc, Tokyo, pp 3-8.

Kirkland D J (1993). Are chromosomal aberration tests in vitro particularly prone to

artificial findings? In "Current Issues in Genetic Toxicology", Eds S Madle & L Müller,

MMV Medizin Verlag, München, pp 43-51.

Kirkland D J (1994). Statistical evaluation of mutagenicity test data: recommendations of

the UK Environmental Mutagen Society (UKEMS).

Environmental Health Perspectives Supplements 102:Suppl 1, 43-47.

Kirkland D J, Galloway S M & Sofuni T (1994). Report of the International Workshop on

Standardisation of Genotoxicity Test Procedures. Summary of major conclusions. Mutat Res

312:205-209.

Kirkland D J (1994). Report of the International Workshop on Standardisation of

Genotoxicity Test Procedures. Report of the In vitro Sub-group. Mutat Res 312:

211-215.

Dr David J Kirkland

Curriculum Vitae

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Galloway S M, Aardema M J, Ishidate M Jr, Ivett J L, Kirkland D J, Morita T, Mosesso P &

Sofuni T (1994). Report from Working group on in vitro tests for chromosomal aberrations.

Mutat Res 312:241-261.

Kirkland D J (1994). New approaches to design and interpretation of in vitro chromosomal

aberration tests. In "Chromosomal alterations: Origin and Significance". Eds G Obe & A T

Natarajan, Springer-Verlag, Berlin, pp 333-342.

Kirkland D J & Dean S W (1994). On the need for confirmation of negative genotoxicity

results in vitro and on the usefulness of mammalian cell mutation tests in a core battery:

experiences of a contract research laboratory. Mutagenesis 9:491-501.

Kirkland D J & Kim N N (1995). Special considerations for conducting genotoxicity tests

with protein materials. Mutagenesis 10:393-398.

Aaron C S, Yu R L, Harbach P R, Mazurek J M, Swenson D H, Kirkland D J, Marshall R &

McEnaney S (1995). Comparative mutagenicity for ceftiofur sodium: I. Positive results in in

vitro cytogenetics. Mutat Res 345:27-35.

Aaron C S, Yu R L, Bacon J A, Kirkland D J, McEnaney S & Marshall R (1995).

Comparative mutagenicity testing of ceftiofur sodium: II. Cytogenetic damage induced

in vitro by ceftiofur is reversible and is due to cell cycle delay. Mutat Res 345:37-47.

Marshall R R, Murphy M, Kirkland D J & Bentley K S (1996). Fluorescence in situ

hybridisation with chromosome-specific centromeric probes: a sensitive method to detect

aneuploidy. Mutat Res 372, 233-245.

Kirkland D J (1998). Use of transgenic animals in toxicology. Pharm. Sci. Technol. Today.

1, 62-68.

Kirkland D J & Clements J (1998). Recommendations for spacing of test chemical

concentrations in the mouse lymphoma tk mutation assay (MLA). Mutat Res 415, 159-163.

Kirkland D J (1998). Chromosome aberration testing in genetic toxicology - past, present

and future. Mutat Res 404, 173-185.

Combes R, Balls M, Curren R, Fischbach M, Fusenig N, Kirkland D J, Lasne C, Landolph J,

LeBoeuf R, Marquardt H, McCormick J, Müller L, Rivedal E, Sabbioni E, Tanaka N, Vaseur

P & Yamasaki H (1999). Cell transformation assays as predictors of human carcinogenicity.

ATLA 27, 745-767.

Bentley K S, Kirkland D J, Murphy M & Marshall R (2000). Evaluation of thresholds for

benomyl- and carbendazim-induced aneuploidy in cultured human lymphocytes using

fluorescence in situ hybridization. Mutat Res 464, 41-51.

Kirkland D J & Müller L (2000). Interpretation of the biological relevance of genotoxicity

test results: the importance of thresholds. Mutat Res 464, 137-147.

Dr David J Kirkland

Curriculum Vitae

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Kirkland D J (2000). Preface to conclusions from International Workshop on Genotoxicity

Test Procedures. Env Mol Muta 35, 159-161.

Kirkland D J, Hayashi M, MacGregor J T, Müller L, Schechtman L & Sofuni T (2000).

Summary of major conclusions from the International Workshop on Genotoxicity Test

Procedures. Env Mol Muta 35, 162-166.

Kirkland D J (2002). The role of the UKEMS in the development of testing guidelines.

Mutagenesis 17(6), 451-455.

Marshall R, Tricta F, Galanello R, Leoni G, Kirkland D J, Minto S & Spino M (2003).

Chromosomal aberration frequencies in patients with thalassemia major undergoing therapy

with Deferiprone and Deferoxamine in a comparative crossover study. Mutagenesis 18(5), 1-

7.

Kirkland D J & Marzin D (2003). An assessment of the genotoxicity of 2-hydroxy-1,4-

naphthoquinone, the natural dye ingredient of Henna. Mutat Res 537, 183-199.

Nohynek G J, Kirkland D, Marzin D, Toutain H, Leclerc-Ribaud C & Jinnai H (2003). An

assessment of the genotoxicity and human health risk of topical use of kojic acid [5-hydroxy-

2-(hydroxymethyl)-4H-pyran-4-one]. Fd Chem Toxicol. 42, 93-105.

Kirkland D J (2003). 3rd

International Workshop on Genotoxicity Tests. Preface. Mutat Res,

540, 119-121.

Kirkland D J, Hayashi M, MacGregor J T, Müller L, Schechtman L M & Sofuni T (2003).

3rd

International Workshop on Genotoxicity Tests. Summary of major conclusions. Mutat

Res, 540, 123-125.

Müller L, Blakey D, Dearfield K L, Galloway S, Guzzie P, Hayashi M, Kasper P, Kirkland

D, MacGregor J T, Parry J M, Schechtman L, Smith A, Tanaka N, Tweats D & Yamasaki H

(2003). Strategy for genotoxicity testing and stratification of genotoxicity test results – report

on initial activities of the IWGT expert group. Mutat Res, 540, 177-181.

Nohynek G J, Kirkland D, Marzin D, Toutain H, Leclerc-Ribaud C and Jinnai H (2004). An

assessment of the genotoxicity and human health risk of topical use of kojic acid [5-hydroxy-

2-(hydroxymethyl)-4H-pyran-4-one]. Fd. Chem. Toxicol. 42, 93-105

Marzin D and Kirkland D (2004). 2-Hydroxy-1,4-naphthoquinone, the natural dye of

Henna, is non-genotoxic in the mouse bone marrow micronucleus test and does not produce

oxidative DNA damage in Chinese hamster ovary cells. Mutat. Res. 560, 41-47.

Kirkland D and Snodin D (2004). Setting limits for genotoxic impurities in drug substances:

Threshold-based and pragmatic approaches. Int. J. Pharm. Med. 18, 197-207

Kasper P, Kirkland D, Leblanc B, Sjöberg P and Spindler P (2004). Acceptability of low

levels of genotoxic impurities in new drug substances: Conclusions of the Drug Information

Dr David J Kirkland

Curriculum Vitae

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Association (DIA)/European Medicines Agency (EMEA) Workshop, October 27-28, 2003 in

London, UK. Int. J. Pharm. Med 18, 221-223

Spindler P, Silva Lima B, Vidal J-M, Kasper P, Sjöberg P, Olejniczak K, Liminga U, van der

Laan J-W, Kirkland D, Newall D R, Bode G and Lodola A (2004). Preclinical Safety

Assessment Update. Drug Information Journal

Kirkland D, Aardema M, Henderson L and Müller L (2005). Evaluation of the ability of a

battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-

carcinogens. I. Sensitivity, specificity and relative predictivity. Mutat. Res. 584, 1-256.

Thompson C, Ferdinandi E, Morley P, Kirkland D and Proudlock R (2005). Modified

bacterial mutation test procedures for evaluation of peptides and amino-acid containing

material. Mutagenesis 20, 345-350.

Kirkland D J, Henderson L, Marzin D, Müller L, Parry J M, Speit G, Tweats D J and

Williams G M (2005). Testing strategies in mutagenicity and genetic toxicology: an appraisal

of the guidelines of the European Scientific Committee for Cosmetics and Non-Food

Products for the evaluation of hair dyes. Mutat. Res. 588, 88-105.

Dufour E K, Kumaravel T, Nohynek G J, Kirkland D and Toutain H (2006). Clastogenicity,

photo-clastogenicity or pseudo-photo-clastogenicity: genotoxic effects of zinc oxide in the

dark, in pre-irradiated or simultaneously-irradiated Chinese hamster ovary cells. Mutat. Res.,

607, 215-224

Garrigue J-L, Ballantyne M, Kumaravel T, Lloyd M, Nohynek G J, Kirkland D and Toutain

H (2006). In vitro genotoxicity of para-phenylenediamine and its N-monoacetyl or N,N’-

diacetyl metabolites. Mutat. Res. 608, 58-71.

Kirkland D, Aardema M, Müller L and Hayashi M (2006). Evaluation of the ability of a

battery of 3 in vitro genotoxicity tests to discriminate rodent carcinogens and non-

carcinogens. II. Further analysis of mammalian cell results, relative predictivity and tumour

profiles. Mutat. Res. 608, 29-42.

Kirkland D and Beevers C (2006). Induction of LacZ mutations in MutaTM

Mouse can

distinguish carcinogenic from non-carcinogenic analogues of diaminotoluenes and

nitronaphthalenes. Mutat. Res. 608, 88-96.

Kirkland D J, Hayashi M, Jacobson-Kram D, Kasper P, MacGregor J T, Müller L and Uno

Y (2007). The International workshops on Genotoxicity Testing (IWGT): History and

achievements. Mutat. Res., 627, 1-4.

Kirkland D J, Hayashi M, Jacobson-Kram D, Kasper P, MacGregor J T, Müller L and Uno

Y (2007). Summary of major conclusions from the 4th

IWGT. Mutat. Res., 627, 5-9.

Thybaud V, Aardema M, Clements J, Dearfield K, Galloway S, Hayashi M, Jacobson-Kram

D, Kirkland D, MacGregor J T, Marzin D, Ohyama W, Schuler M, Suzuki H and Zeiger E

Dr David J Kirkland

Curriculum Vitae

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(2007). Strategy for genotoxicity testing: Hazard identification and risk assessment in relation

to in vitro testing. Mutat. Res., 627, 41-58.

Kirkland D, Whitwell J, Deyo J and Serex T (2007). Failure of antimony trioxide to induce

micronuclei or chromosomal aberrations in rat bone marrow after sub-chronic dosing. Mutat.

Res., 627, 119-128.

Kirkland D, Pfuhler S, Tweats D, Aardema M, Corvi R, Darroudi F, Elhajouji A, Glatt H

Hastwell P, Hayashi M, Kasper P, Kirchner S, Lynch A, Marzin D, Maurici D, Meunier J-R,

Müller L, Nohynek G, Parry J, Parry E, Thybaud V, Tice R, van Benthem J, Vanparys P and

White P (2007). How to reduce false positive results when undertaking in vitro genotoxicity

testing and thus avoid unnecessary follow-up animal tests: Report of an ECVAM workshop.

Mutat. Res., 628, 31-55.

Tice R R, Gatehouse D, Kirkland D and Speit G (2007). The pathogen reduction treatment

of platelets with S-59 HCl (Amotosalen) plus ultraviolet A light: Genotoxicity profile and

hazard assessment. Mutat. Res. 630, 50-68.

Kirkland D J, Aardema M, Banduhn N, Carmichael P, Fautz R, Meunier J-R and Pfuhler S

(2007). In vitro approaches to develop weight of evidence (WoE) and mode of action (MoA)

discussions with positive in vitro genotoxicity results. Mutagenesis 22, 161-175.

Long L H, Kirkland D and Halliwell B (2007) Different cytotoxicities of epigallocatechin

gallate or ascorbate in various cell culture media due to variable rates of oxidation in the

culture medium. Mutat. Res. 634, 177-183.

Theogaraj E, Riley S, Hughes L, Maier M and Kirkland D (2007). An investigation of the

photo-clastogenic potential of ultrafine titanium dioxide particles. Mutat. Res. 634, 205-219.

Kirkland D, Kasper P, Müller L, Corvi R and Speit G (2008). Recommended lists of

genotoxic and non-genotoxic chemicals for assessment of the performance of new or

improved genotoxicity tests: A follow-up to an ECVAM workshop. Mutat. Res. 653, 99-108.

Kirkland D and Speit G (2008). Evaluation of the ability of a battery of 3 in vitro

genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. III. Appropriate

follow-up testing in vivo. Mutat. Res. 654, 114-132.

Lorge E, Hayashi M, Albertini S and Kirkland D (2008). Comparison of different methods

for an accurate assessment of cytotoxicity in the in vitro micronucleus test. I. Theoretical

aspects. Mutat. Res. 655, 1-3

Fellows M D, O’Donovan M R, Lorge E and Kirkland D (2008). Comparison of different

methods for an accurate assessment of cytotoxicity in the in vitro micronucleus test. II.

Practical aspects with toxic agents. Mutat. Res. 655, 4-21

Blakey D, Galloway S M, Kirkland D J and MacGregor J T (2008). Regulatory aspects of

genotoxicity testing: from hazard identification to risk assessment. Mutat. Res. 657, 84-90.

Dr David J Kirkland

Curriculum Vitae

Page 12

Dufour E K, Whitwell J, Nohynek G J, Kirkland D and Toutain H (2009). Retinyl palmitate

is non-genotoxic in Chinese hamster ovary cells in the dark or after pre-irradiation or

simultaneous irradiation with UV light. Mutat. Res. 672, 21-26

Benfenati E, Benigni R, DeMarini D M, Helma C, Kirkland D, Martin T M, Mazzatorta P,

Ou´edraogo-Arras G, Richard A M, Schilter B, Schoonen W G E J, Snyder R D and Yang C

(2009). Predictive Models for Carcinogenicity and Mutagenicity: Frameworks, State-of-the-

Art, and Perspectives. J. Env. Sci. Health Part C, 27, 57-90.

Kirsch-Volders M, Gonzalez L, Carmichael P and Kirkland D (2009). Risk assessment of

genotoxic mutagens with thresholds: A brief introduction. Mutat. Res. 678, 72-75.

Eichenbaum G, Johnson M, Kirkland D, O’Neill P, Stellar S, Bielawne J, DeWire R, Areia

D, Bryant S, Weiner S, Desai-Krieger D, Guzzie-Peck P, Evans D C and Tonelli A (2009).

Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an

impurity in a drug product. Regul. Tox. Pharm. 55, 33-42.

Pfuhler S, Kirkland D, Kasper P, Hayashi M, Vanparys P, Carmichael P, Dertinger S,

Eastmond D, Elhajouji A, Krul C, Rothfuss A, Schoening G, Smith A, Speit G, Thomas C,

van Benthem J and Corvi R (2009). Reduction of use of animals in regulatory genotoxicity

testing: Identification and implementation opportunities—Report from an ECVAM

workshop. Mutat. Res.680, 31-42.

Kirkland D (2010). Evaluation of different cytotoxic and cytostatic measures for the in vitro

micronucleus test (MNVit): Introduction to the collaborative trial. Mutat. Res. 702, 135-138.

Kirkland D (2010). Evaluation of different cytotoxic and cytostatic measures for the in vitro

micronucleus test (MNVit): Summary of results in the collaborative trial. Mutat. Res. 702,

139-147.

Fowler P, Whitwell J, Jeffrey L, Young J, Smith K and Kirkland D (2010). Cadmium

chloride, benzo[a]pyrene and cyclophosphamide tested in the in vitro mammalian cell

micronucleus test (MNvit) in the human lymphoblastoid cell line TK6 at Covance

laboratories, Harrogate UK in support of OECD draft Test Guideline 487. Mutat. Res. 702,

171-174

Fowler P, Whitwell J, Jeffrey L, Young J, Smith K and Kirkland D (2010). Etoposide;

colchicine; mitomycin C and cyclophosphamide tested in the in vitro mammalian cell

micronucleus test (MNvit) in Chinese hamster lung (CHL) cells at Covance laboratories;

Harrogate UK in support of OECD draft Test Guideline 487. Mutat. Res. 702, 175-180.

Whitwell J, Fowler P, Allars S, Jenner K, Lloyd M, Wood D, Smith K, Young J, Jeffrey L,

Kirkland D (2010). 5-Fluorouracil, colchicine, benzo[a]pyrene and cytosine arabinoside

tested in the in vitro mammalian cell micronucleus test (MNvit) in Chinese hamster V79 cells

at Covance Laboratories, Harrogate, UK in support of OECD draft Test Guideline 487.

Mutat. Res. 702, 230-236.

Dr David J Kirkland

Curriculum Vitae

Page 13

Whitwell J, Fowler P, Allars S, Jenner K, Lloyd M, Wood D, Smith K, Young J, Jeffrey L,

Kirkland D (2010). 2-Aminoanthracene, 5-fluorouracil, colchicine, benzo[a]pyrene,

cadmium chloride and cytosine arabinoside tested in the in vitro mammalian cell

micronucleus test (MNvit) in Chinese hamster ovary (CHO) cells at Covance Laboratories,

Harrogate UK in support of OECD draft Test Guideline 487. Mutat. Res. 702, 237-247. Kirkland D and Fowler P (2010). Further analysis of Ames-negative rodent carcinogens that

are only genotoxic in mammalian cells in vitro at concentrations exceeding 1 mM, including

retesting of compounds of concern. Mutagenesis 25, 539-553.

Dearfield K L, Thybaud V, Cimino M C, Custer L, Czich A, Harvey J S, Hester S, Kim J H,

Kirkland D, Levy D D, Lorge E, Moore M M, Ouédraogo-Arras G, Schuler M, Suter W,

Sweder K, Tarlo K, van Benthem J, van Goethem F and Witt K L (2011). Follow-up actions

from positive results of in vitro genetic toxicity testing. Environ. Mol. Mutagen. 52, 177-204.

Kirkland D, Reeve L, Gatehouse D and Vanparys P (2011). A core in vitro genotoxicity

battery comprising the Ames test plus the in vitro micronucleus test is sufficient to detect

rodent carcinogens and in vivo genotoxins. Mutat. Res. 721, 27-73.

Bowen D E, Whitwell J H, Lillford L, Henderson D, Kidd D, McGarry S, Pearce G, Beevers

C and Kirkland D J (2011). Evaluation of a multi-endpoint assay in rats, combining the

bone-marrow micronucleus test, the Comet assay and the flow-cytometric peripheral blood

micronucleus test. Mutat. Res. 722, 7-19.

Galloway S, Lorge E, Aardema M J, Eastmond D, Fellows M, Heflich R, Kirkland D, Levy

D D, Lynch A M, Marzin D, Morita T, Schuler M and Speit G (2011). Workshop summary:

Top concentration for in vitro mammalian cell genotoxicity assays; and report from working

group on toxicity measures and top concentration for in vitro cytogenetics assays

(chromosome aberrations and micronucleus). Mutat. Res. 723, 77-83.

Rothfuss A, Honma M, Czich A, Aardema M J, Burlinson B, Galloway S, Hamada S,

Kirkland D, Heflich R H, Howe J, Nakajima M, O’Donovan M, Plappert-Helbig U, Priestley

C, Recio L, Schuler M, Uno Y and Martus H-J (2011). Improvement of in vivo genotoxicity

assessment: Combination of acute tests and integration into standard toxicity testing. Mutat.

Res. 723, 108-120.

Kirkland D J, Hayashi M, Jacobson-Kram D, Kasper P, Gollapudi B, Müller L and Uno Y

(2011). Summary of major conclusions from the 5th IWGT, Basel, Switzerland, 17–19

August 2009, Mutat. Res. 723, 73-76.

Felter SP, Conolly RB, Bercu JP, Bolger PM, Boobis AR, Bos PMJ, Carthew P, Doerrer NG,

Goodman JI, Harrouk WA, Kirkland DJ, Lau SS, Llewellyn GC, Preston RJ, Schoeny R,

Schnatter AR, Tritscher A, van Velsen F, and Williams GM (2011). A proposed framework

for assessing risk from less-than-lifetime exposures to carcinogens. Crit. Rev. Toxicol. 41,

507-544.

Dr David J Kirkland

Curriculum Vitae

Page 14

Kirkland D, Ballantyne M, Harlfinger S, Will O, Jahnel U, Kraus A and van Dorp C (2011).

Further investigations into the genotoxicity of 2,6-xylidine and one of its key metabolites.

Regul. Toxicol. Pharmacol.62, 151-159.

Kirkland D (2011). Improvements in the reliability of in vitro genotoxicity testing. Expert

Opin. Drug Metab. Toxicol. 7, 1513-1520.

Fowler P, Smith K, Young J, Jeffrey L, Kirkland D, Pfuhler S and Carmichael P (2012).

Reduction of misleading (“false”) positive results in mammalian cell genotoxicity assays. I.

Choice of cell type. Mutat. Res. 742, 11-25

McKeon M, Xu Y, Kirkland D, Schmuck G, Krebsfänger N, Avlasevich S L and Dertinger S

D (2012). Cyclophosphamide and etoposide canine studies demonstrate the cross-species

potential of the flow cytometric peripheral blood micronucleated reticulocyte endpoint.

Mutat. Res. 742, 79-83.

Fowler P, Smith R, Smith K, Young J, Jeffrey L, Kirkland D, Pfuhler S, Carmichael P

(2012). Reduction of misleading (“false”) positive results in mammalian cell genotoxicity

assays. II. Importance of accurate toxicity measurement. Mutat. Res. 747, 104-117.

Kier L D, Kirkland D J (2013). Review of genotoxicity studies of glyphosate and

glyphosate-based formulations. Crit. Rev. Toxicol. 43, 283-315.

Fowler P, Smith R, Smith K, Young J, Jeffrey L, Carmichael P, Kirkland D, Pfuhler S

(2014). Reduction of misleading ("false") positive results in mammalian cell genotoxicity

assays. III. Sensitivity of human cell types to known genotoxic agents, Mutat. Res. 767, 28-

36.

Kirkland D, Zeiger E, Madia F, Gooderham N, Kasper P, Lynch A, Morita T, Ouedraogo G,

Parra Morte J M, Pfuhler S, Rogiers V, Schulz M, Thybaud V, van Benthem J, Vanparys P,

Worth A, Corvi R (2014). Can in vitro mammalian cell genotoxicity test results be used to

complement positive results in the Ames test and help predict carcinogenic or in vivo

genotoxic activity? I. Reports of individual databases presented at an EURL ECVAM

Workshop, Mutat. Res.775-776, 55-68.

Kirkland D, Zeiger E, Madia F, Corvi R (2014). Can in vitro mammalian cell genotoxicity

test results be used to complement positive results in the Ames test and help predict

carcinogenic or in vivo genotoxic activity? II. Construction and analysis of a consolidated

database, Mutat. Res. 775-776, 69-80.

Kirkland D, Edwards J, Woehrle T, Beilstein P (2015). Investigations into the genotoxic

potential of olive extracts. Mutat. Res. 777, 17-28.

Martus H-J, Hayashi M, Honma M, Kasper P, Gollapudi B, Müller L, Schoeny R, Uno Y,

Kirkland D J (2015). Summary of major conclusions from the 6th International Workshop

on Genotoxicity Testing (IWGT), Foz do Iguaçu, Brazil. Mutat. Res. 783, 1-5.

Dr David J Kirkland

Curriculum Vitae

Page 15

Whitwell J, Smith R, Jenner K, Lyon H, Wood D, Clements J, Gollapudi B, Kirkland D,

Lorge E, Pfuhler S, Tanir J, Thybaud V (2015). Relationship between p53 status, apoptosis

and induction of micronuclei in different human and mouse cell lines in vitro: implications

for improving existing assays. Mutat. Res.789-790, 7-27.

Kirkland D, Brock T, Haddouk H, Hargeaves V, Lloyd M, Mc Garry S, Proudlock R,

Sarlang S, Sewald K, Sire G, Sokolowski A, Ziemann C (2015). New investigations into the

genotoxicity of cobalt compounds and their impact on overall assessment of genotoxic risk.

Regul. Toxicol. Pharmacol. 73, 311-338.

Kirkland D, Gatehouse D (2015). Aspartame: a review of genotoxicity data. Food Chem.

Toxicol. 84, 161-168.

SCIENTIFIC PRESENTATIONS AND INVITED LECTURES

Too numerous to list.