Acetone

Repeated dose toxicity: dermal

Administrative data

Endpoint:

chronic toxicity: dermal

Type of information:

experimental study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Studies meeting generally accepted scientific principles with several limitations (single dose tested, no values for untreated control mice), studies acceptable as supporting information for data waiving

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Pathology of aging female SENCAR mice used as controls in skin two-stage carcinogenesis studies

Author:

Ward J, Quander RD, Wenk M, Spangler E

Year:

1986

Bibliographic source:

Environ Health Perspect 68: 81-89

Reference 2

Reference Type:

publication

Title:

Dermal oncogenicity studies on two methoxysilanes and two ethoxysilanes in male C3H mice

Author:

DePass LR, Ballantyne B, Fowler EH, Weil CS

Year:

1989

Bibliographic source:

Fund Appl Toxicol 12: 579-583

Reference 3

Reference Type:

publication

Title:

Two-year carcinogenicity study on three aromatic epoxy resins applied cutaneously to CF1 mice

Author:

Peristianis GC, Doak SM, Cole PN, Hend RW

Year:

1988

Bibliographic source:

Fd Chem Toxicol 26: 611-624

Reference 4

Reference Type:

publication

Title:

Evaluation of skin carcinogenicity of technical 2,2-bis-(p-glycidyloxyphenyl)-propane in CF1 mice

Author:

Zakova N, Zak F, Froehlich E, Hess R

Year:

1985

Bibliographic source:

Food Chem Toxicol 23: 1081-1089

Reference 5

Reference Type:

publication

Title:

The skin tumorigenic and carcinogenic effects of different doses, numbers of dose fractions and concentrations of 7,12-dimethylbenz[a]anthracene in acetone applied on hairless mouse epidermis. Possible implications for human carcinogenesis

Author:

Iversen OH

Year:

1991

Reference 6

Reference Type:

publication

Title:

Cigarette smoke carcinogenesis: importanc eof tumor promoters

Author:

Van Duuren BL, Sivak A, Katz C, Melchionne S

Year:

1971

Bibliographic source:

J Nat Cancer Inst 47: 235-240

Reference 7

Reference Type:

publication

Title:

Mouse skin carcinogenicity tests of the flame retardants tris(2,3-dibromopropyl)phosphate, tetrakis(hydroxymethyl)phosphonium chloride, and polyvinyl bromide

Author:

Van Duuren BL, Loewengart G, Seldman I, Smith AC, Melchionne S

Year:

1978

Bibliographic source:

Cancer Res 38: 3236-3240

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Acetone

EC Number:

200-662-2

EC Name:

Acetone

Cas Number:

67-64-1

Molecular formula:

C3H6O

IUPAC Name:

propan-2-one

Administration / exposure

Doses / concentrations

Remarks:

Doses / Concentrations:

Basis:

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Acetone has been applied as solvent in several dermal carcinogenicity studies with different strains of mice. Consequently, there is experience with up to lifetime dermal exposure to low doses of acetone with test volumes of 0.025 to 0.2 ml corresponding to doses of ca. 20 to 160 mg acetone/mouse with 2 or 3 treatments per week for up to 573 days. In these studies no noticeable effects on survival or incidence of skin neoplasms was described for the acetone-treated solvent control groups.No other endpoints were examined. Principally, these data point in the direction that the low acute dermal toxicity of acetone would be confirmed upon chronic administration.

Additionally, due to the volatility of acetone, standard conditions of dermal application will result in considerable evaporation from the skin surface so that the effective dose for dermal uptake will be reduced. Consequently, a dermal repeated dose toxicity study does not seem to be scientifically justified.

Applicant's summary and conclusion

Executive summary:

Acetone has been applied as solvent in several dermal carcinogenicity studieswith different strains of mice. Consequently, there is experience with up to lifetime dermal exposure to low doses of acetone with testvolumes of 0.025 to 0.2 ml corresponding to doses of ca. 20 to 160 mg acetone/mouse with 2 or 3 treatments per week for up to lifetime (up to 573 days). In these studies no noticeable effects on survival or incidence of skin neoplasms was described for the acetone-treated solvent control groups.No other endpoints were examined. Principally, these data point in the direction thatthe low acute dermal toxicity of acetone would be confirmed upon chronic administration. Additionally, due to the volatility of acetone, standard conditions of dermal application will result in considerable evaporation from the skin surface so that the effective dose for dermal uptake will be reduced. Consequently, a dermal repeated dose toxicity study does not seem to be scientifically justified.