1,1,3-trichloroacetone

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: following a guideline with limited documentation, only for skin tumors

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Mouse skin assay with topically administered 50 mg/kg of test material, administered 6 times over 2 weeks (all together 300 mg/kg)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3-trichloroacetone

EC Number:

213-063-6

EC Name:

1,1,3-trichloroacetone

Cas Number:

921-03-9

Molecular formula:

C3H3Cl3O

IUPAC Name:

1,1,3-trichloropropan-2-one

Details on test material:

- Name of test material (as cited in study report): 1,1,3-Trichloroacetone
- Physical state: liquid
- Analytical purity: 95
- Impurities (identity and concentrations): 1,3-Dichloroacetone (1.4%), 1,1,3,3-Tetrachloroacetone

Test animals

Species:

mouse

Strain:

Sencar

Sex:

female

Details on test animals or test system and environmental conditions:

Sencar mice from Harlan-SpragueDawley, Indianapolis, IN, USA

Administration / exposure

Route of administration:

dermal

Vehicle:

ethanol

Details on exposure:

300 mg/kg

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

not applicable

Duration of treatment / exposure:

6 administrations each 50 mg/kg

Frequency of treatment:

6 times/ 2 weeks

Post exposure period:

24 weeks

Doses / concentrations

Remarks:

Doses / Concentrations:
300 mg/kg
Basis:
nominal conc.

No. of animals per sex per dose:

39 animals

Control animals:

yes, concurrent vehicle

Details on study design:

- Dose selection rationale: toxcicity
- Rationale for animal assignment (if not random): random

Positive control:

not applicable

Examinations

Observations and examinations performed and frequency:

not reported

Sacrifice and pathology:

not reported

Other examinations:

none reported

Statistics:

cumulative tumor count with log rank test

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

effects observed, treatment-related

Details on results:

tumors below control groups

Relevance of carcinogenic effects / potential:

Amount of tumors induced is statistically not significant

Applicant's summary and conclusion

Conclusions:

1,1,3-Trichloroacetone showed no statistically relevant induction of tumors under the conditions used.

Executive summary:

In a mouse skin assay 1,1,3 -trichloroacetone was assessed for its ability to induce skin tumors after repeated application. 39 female Sencar mice were administered with 50 mg/kg test substance in 0.2 ml ethanol for 6 times within two weeks. Control animals received 0.2 ml ethanol per application. Two weeks after the final dose, 1.0µg TPA (12-O-tetradecanoyl-phorbol-13-acetate) in 0.2 ml acetone was applied three times weekly for 20 weeks. After 24 weeks the percentage of animals with tumors was determined in order to classify the carcinogenetic activity of the test substance. 1,1,3-Trichloroacetone showed no statistically relevant induction of tumors in the mouse skin under the conditions used.