Final report on the safety assessment of methyldibromo glutaronitrile

Journal of the American College of Toxicology

Volumn 15, Issue 2, 1996, Pages 140-165

  Andersen, F A ^a  

^a Cosmetic Ingredient Review ^*  (United States)

Author keywords

Cosmetic use; Leave on formulation; Methyldibromo Glutaronitrile; Repeat insult patch testing; Rinse off formulation

Indexed keywords

2 BROMO 2 BROMOMETHYLGLUTARONITRILE; COSMETIC; PRESERVATIVE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CHRONIC TOXICITY; CONTROLLED STUDY; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG METABOLISM; DRUG SAFETY; EYE IRRITATION; GENOTOXICITY; NONHUMAN; PATCH TEST; PHOTOSENSITIZATION; PHOTOTOXICITY; RAT; RISK ASSESSMENT; SKIN IRRITATION; SKIN SENSITIZATION;

EID: 0030007207     PISSN: 07300913     EISSN: None     Source Type: Journal    
DOI: 10.3109/10915819609043793     Document Type: Article

References (66)

1. Andersen HE, Rycroft RJG. (1991) Recommended patch test concentrations for preservatives, biocides and antimicrobials. Contact Dermatitis 25:1-18.
2. Berger DS. (1976) The sunburning ultraviolet meter: design and performance. Photochem Photobiol 24:587-93.
3. Biosearch Incorporated. (1982a) Guinea pig sensitization study Magnusson-Kligman-maximization method (Project No. 81-2824A). Unpublished data (Appendix 18) submitted by Calgon Corporation, February 1, 1994 (13 pages).*
4. Biosearch Incorporated. (1982b) Ritz-Buehler guinea pig contact dermal irritation sensitization study (Project No. 81-2813A). Unpublished data (Appendix 19) submitted by Calgon Corporation, February 1, 1994 (13 pages).*
5. Biosearch Incorporated. (1982c) Acute Dermal Toxicity Study (Project No. 82-2983A). Unpublished data (Appendix 8) submitted by Calgon Corporation, February 1, 1994 (5 pages).*
6. Biosearch Incorporated. (1982d) Primary Eye Irritation Study (Project No. 82-2983A). Unpublished data (Appendix 10) submitted by Calgon Corporation, February 1, 1994 (5 pages).*
7. Birnbaum HA, Harris SB, Holson JF, Keener SK. (1983) Teratological evaluation of methyldibromo-glutaronitrile in rats. Toxicol Lett 18(suppl 1):158.
8. Bruze M, Gruvberger B, Agrup G. (1988) Sensitization studies in the guinea pig with the active ingredients of Euxyl K 400. Contact Dermatitis 18:37-9.
9. Bushy Run Research Center. (1990) In vitro skin penetration following a single application to the excised skin of humans and Sprague-Dawley rats (BRRC No. 89-48-70725). Unpublished data (Appendix 6) submitted by Calgon Corporation, February 1, 1994 (8 pages).*
10. Calgon Corporation. (1994) Methyldibromo Glutaronitrile Summary Information. Unpublished data submitted by Calgon Corporation, February 1, 1994 (15 pages).*
11. Cosmetic, Toiletry, and Fragrance Association (CTFA). (1982a) 28-day subchronic percutaneous toxicity. Unpublished data (section 15) submitted by CTFA, February 14, 1994 (72 pages).*
12. CTFA. (1982b) The absorption and elimination of tektamer 38 after cutaneous application to rats. Unpublished data (section 2) submitted by CTFA, February 14, 1994 (21 pages).
13. deGroot AC, Bruynzeel DP, Coenraads PJ, et al. (1991) Frequency of allergic reactions to methyldibromo-glutaronitrile (1,2-dibromo-2,4-dicyanobutane) in the Netherlands. Contact Dermatitis 25:270-1.
14. DeKruijf N, Rijk MAH, Pranoto-Soetardhi LA, Schouten A. (1987) Determination of preservatives in cosmetic products. 1. Thin-layer chromatographic procedure for the identification of preservatives in cosmetic products. J Chromatogr 410:395-411.
15. Dermatest. (1990) Report on a Human Patch Test. Unpublished data submitted by Biochema Schwaben, May 10, 1994 (5 pages).*
16. European Economic Community (EEC). (1993) EEC Cosmetics Directive 76/768/EEC, as amended, Annexes I through VII. Brussels: EEC.
17. EG & G Mason Research Institute. (1981) L5178Y TK + /- mouse lymphoma mutagenesis assay. Unpublished data (Appendix 23) submitted by Calgon Corporation, February 1, 1994 (4 pages).*
18. EG & G Mason Research Institute. (1982) Test for chemical induction of mutation in mammalian cells in culture. The L51178Y Tk +/- Mouse Lymphoma Assay (Study No. 003-562-725-7). Unpublished data (section 4) submitted by CTFA, February 14, 1994 (97 pages).*
19. Food and Drug Administration (FDA). (1994) Frequency of use of cosmetic ingredients. FDA database. Washington, D.C.: FDA.
20. Fuchs T, Enders F, Przybilla B, et al. (1991) Contact Allergy to Euxyl K 400. Dermatosen 39:151-3.
21. Hausen BM. (1993) The sensitizing potency of Euxyl K 400 and its components 1,2-dibromo-2,4-dicyanobutane and 2-phenoxyethanol. Contact Dermatitis 28:149-53.
22. Hazleton Laboratories America, Inc. (1980a) Modified dominant lethal evaluation in mice (Project No. 994-123). Unpublished data (Appendix 26) submitted by Calgon Corporation, February 1, 1994 (8 pages).*
23. Hazleton Laboratories America, Inc. (1980b) Thirteen-week subchronic dietary administration in dogs (Project No. 994-124). Unpublished data (Appendix 14) submitted by Calgon Corporation, February 1, 1994 (15 pages).*
24. Hazleton Laboratories America, INc. (1980c) Ninety-day feeding study in rats exposed in utero (Project No. 994-125). Unpublished data (Appendix 31) submitted by Calgon Corporation, February 1, 1994 (21 pages).*
25. 4 toxicity study in dogs (Project No. 994-127). Unpublished data (Appendix 15) submitted by Calgon Corporation, February 1, 1994 (15 pages).*
26. Hill Top Biolabs, Inc. (1988) Delayed hypersensitivity study in guinea pigs (Project No. 88-3187-21). Unpublished data (Appendix 17) submitted by Calgon Corporation, February 1, 1994 (8 pages).*
27. Hill Top Research, Inc. (1981a) Human sensitization test protocol (Study No. 83-0051-72). Unpublished data (section 5) submitted by CTFA, February 14, 1994 (29 pages).*
28. Hill Top Research, Inc. (1981b) Delayed contact hypersensitivity study in guinea pigs of T0976.01 (Project No. 81-0551-21). Unpublished data (section 18) submitted by CTFA, February 14, 1994 (33 pages).*
29. Hill Top Research, Inc. (1981c) Repeat Insult Patch Test (Project No. 81-1148-72B). Unpublished data (section 9) submitted by CTFA, February 14, 1994 (77 pages).*
30. Hill Top Research, Inc. (1982a) Delayed contact hypersensitivity study in guinea pigs of G0003.01 (Project No. 81-1586-21). Unpublished data (section 6) submitted by CTFA, February 14, 1994 (48 pages).*
31. Hill Top Research, Inc. (1982b) Delayed contact hypersensitivity study in guinea pigs of G0003.01, including cross challenge with G0003.02 (Project No. 81-1587-21). Unpublished data (section 1) submitted by CTFA, February 14, 1994 (46 pages).*
32. Hill Top Research, Inc. (1982c) Delayed contact hypersensitivity study in guinea pigs of B0453-01 - Study No. 1 (Project No. 82-0282-21). Unpublished data (section 8) submitted by CTFA, February 14, 1994 (45 pages).*
33. Hill Top Research, Inc. (1983) Repeat Insult Patch Test (Project No. 82-1412-72). Unpublished data (section 7) submitted by CTFA, February 14, 1994 (75 pages).*
34. Hill Top Research, Inc. (1984a) Repeat Insult Patch Test (Project No. 82-1082-72B). Unpublished data (section 16) submitted by CTFA, February 14, 1994 (49 pages).*
35. Hill Top Research, Inc. (1984b) Repeat Insult Patch Test (Project No. 84-0344-72 (A and B)). Unpublished data (section 3) submitted by CTFA, February 14, 1994 (150 pages).*
36. International Bio Research (IBR). (1987a) Euxyl K 400 (TPI 1100) Experimental investigation on phototoxic effects in guinea-pigs (Project No: 2-5-661-87). Unpublished data submitted by Schulke & Mayr GmbH, April 29, 1994 (15 pages).*
37. IBR. (1987b) Euxyl K 400 (TPI 1100) Experimental investigation on photosensitizing effects in guinea pigs (Project No: 2-5-660-87). Unpublished data submitted by Schulke & Mayr GmbH, April 29, 1994 (18 pages).*
38. IBR. (1988a) Sensitization Testing in Guinea-Pigs, modified method of B. Magnusson and A. M. Kligman (Project No: 2-5-838-88). Unpublished data submitted by Biochema Schwaben, May 10, 1994 (19 pages).*
39. IBR. (1988b) Sensitization Testing in Guinea-pigs, modified method of B. Magnusson and A. M. Kligman (Project No: 2-5-381-83/0-0-1732-88). Unpublished data submitted by Schulke & Mayr GmbH, April 29, 1994 (19 pages).*
40. 14C)-DBDCB in the rat. Unpublished data (Appendix 5) submitted by Calgon Corporation, February 1, 1994 (12 pages).*
41. Langner K, Streck M, Petersen D, Voss J. (1988) Differential pulse polarography - a convenient method of quantitative determination of 2-bromo-2-bromomethylpentanedinitrile ("1,2-dibromo-2,4-dicyanobutane"). Fresenius' Z Anal Chem 332:823.
42. Litton Bionetics, Inc. (1984) In vitro transformation of BALB/C-3T3 cells assay with S9 activation (LBI Safety NO. 10448-001). Unpublished data (Appendix 25) submitted by Calgon Corporation, February 1, 1994 (6 pages).*
43. Mathias CGT. (1983) Contact dermatitis to a new biocide (Tektamer 38) used in a paste glue formulation. Contact Dermatitis 9:418.
44. MB Research Laboratories, Inc. (1983) Eye Irritation Study in Rabbits (Project No. MB 83-6538 D). Unpublished data (Appendix 11) submitted by Calgon Corporation, February 1, 1994 (4 pages).*
45. MB Research Laboratories, Inc. (1991a) Single Dose Oral Toxicity in Rats (Project No. MB 90-106-A). Unpublished data (Appendix 7) submitted by Calgon Corporation, February 1, 1994 (4 pages).*
46. MB Research Laboratories, Inc. (1991b) Primary Dermal Irritation in Albino Rabbits (Project No. MB 90-106-C). Unpublished data (Appendix 12) submitted by Calgon Corporation, February 1, 1994 (3 pages).*
47. MR Research Laboratories, Inc. (1992a) 21-day repeated dose dermal toxicity study in rats (Project No. MB 90-334). Unpublished data (Appendix 13) submitted by Calgon Corporation, February 1, 1994 (7 pages).*
48. MR Research Laboratories, Inc. (1992b) Acute Inhalation Toxicity in Rats (Project No. MB 91-334 E). Unpublished data (Appendix 9) submitted by Calgon Corporation, February 1, 1994 (5 pages).*
49. Merck, Sharp, & Dohme Research Laboratories. (1978) Microbial mutagen test with and without rat liver enzyme activation. Unpublished data (Appendix 29) submitted by Calgon Corporation, February 1, 1994 (4 pages).*
50. Merck, Sharp, & Dohme Research Laboratories. (1983) Measurement of unscheduled DNA synthesis in human IMR-90 fibroblasts. Unpublished data (Appendix 20) submitted by Calgon Corporation, February 1, 1994 (6 pages).*
51. Merck, Sharp, & Dohme Research Laboratories. (1985) V-79 mammalian cell mutagenesis. Unpublished data (Appendix 28) submitted by Calgon Corporation, February 1, 1994 (6 pages).*
52. Microbiological Associates, Inc. (1982a) Cytogenicity study of chinese hamster ovary (CHO) cells in vitro (Study No. T1752.338). Unpublished data (Appendix 30) submitted by Calgon Corporation, February 1, 1994 (6 pages).*
53. Microbiological Associates. (1982b) In vivo cytogenetics assay in Sprague-Dawley rats. Unpublished data (Appendix 27) submitted by Calgon Corporation, February 1, 1994 (6 pages).*
54. Microbiological Associates. (1990) Morphological transformation of BALB/3T3 mouse embryo cells (MBA Study T9045.304013). Unpublished data (Appendix 24) submitted by Calgon Corporation, February 1, 1994 (8 pages).*
55. Microbiological Associates, Inc. (1991) Acute in vivo cytogenetics assays in rats (MA Study No. T9876.105012). Unpublished data (Appendix 21) submitted by Calgon Corporation, February 1, 1994 (4 pages).*
56. Motolese A, Seildenari S, Truzzi M, Gianetti A. (1991) Frequency of contact sensitization to Euxyl K 400. Contact Dermatitis 25:128.
57. Pigatto PD, Bigardi A, Legori A, Altomare GF, Carminati G. (1991) Allergic contact dermatitis from Tektamer 38 (dibromodicyanobutane). Contact Dermatitis 25:138-9.
58. Q-Test, Inc. (1981) Phototoxicity test on sample T0976.01 (Study No. Q81-004). Unpublished data (section 11) submitted by CTFA, February 14, 1994 (58 pages).*
59. Rooselaar J, Weyland JW. (1993) Determination of methyldibromoglutaronitrile in cosmetic products by high-performance liquid chromatography with electrochemical detection. Int J Cosmet 15:23-31.
60. Ross JS, Cronin E, White IR, Rycroft RJG. (1992) Contact dermatitis from Euxyl K 400 in cucumber eye gel. Contact Dermatitis 26:60.
61. Senff H, Exner M, Gorz J, Goos M. (1989) Allergic contact dermatitis from Euxyl K 400. Contact Dermatitis 20:381-2.
62. Tosti A, Guerra L, Bardazzi F, Gasparri F. (1991) Euxyl K 400: a new sensitizer in cosmetics. Contact Dermatitis 25:89-93.
63. University of Wisconsin Zoology Department. (1992) Drosophila melanogaster somatic mutation and recombination test assay (UW Study No. 135). Unpublished data (Appendix 22) submitted by Calgon Corporation, February 1, 1994 (6 pages).*
64. Wenninger JW, McEwen GN Jr, eds. (1992) CTFA Cosmetic Ingredient Handbook. 2nd ed. Washington, D.C.: CTFA, 235.
65. Wenninger JA, McEwen GN Jr, eds. (1993) International Cosmetic Ingredient Dictionary; vol 1. 5th ed. Washington: CTFA, 401.
66. Wojciechowski M, Osteryoung J. (1985) Electrochemistry and reverse pulse polarographic determination of 1,2-dibromo-2,4-dicyanobutane. Anal Chem 57:927-33.