Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.