Registration Dossier

Administrative data

Endpoint:
carcinogenicity
Remarks:
intraperitoneal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: No guideline and no GLP data. The intraperitoneal route is not relevant and the animals were only administered the substance three times weekly.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1979

Materials and methods

Principles of method if other than guideline:
Groups of 20 mice (10 males and 10 females) were given 3 times weekly i.p. injections of the maximum tolerated dose, one-half of the tolerated dose and either one-forth or one-fifth the maximum tolerated dose. Twenty-four weeks after the first injection, the mice were sacrificed and the lungs were examined.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyl chloroacetate

Test animals

Species:
mouse
Strain:
Strain A
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: Tricaprylin
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
Twenty-four weeks
Frequency of treatment:
3 times weekly
Doses / concentrations
Remarks:
Doses / Concentrations:
0.09, 0.18, 0.36 mmol/kg bw/injection
Basis:
nominal conc.
No. of animals per sex per dose:
10 animals per sex per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:
The meaningfulness of ths method is limited. In this carcinogenicity test, the induction of lung tumours occurs wiwth a high incidence in the mouse strain used and is frequently brought about following administration of a carcinogenic substance.

Applicant's summary and conclusion

Conclusions:
Methyl chloroacetate was not tumorigenic by pulmonary adenoma bioassay.
Executive summary:

Groups of 20 mice (10 males and 10 females) were given 3 times a week for 8 weeks i.p. injections of the maximum tolerated dose, one-half of the tolerated dose and either one-forth or one-fifth the maximum tolerated dose (0.36, 0.18 and 0.09 mmol/kg bw, respectively). Twenty-four weeks after the first injection, the mice were sacrificed and the lungs were examined. No increased incidence of lung tumours was found. Methyl chloroacetate was not tumorigenic by pulmonary adenoma bioassay.