Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The original study was not obtained by the reviewer.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1954
Report Date:
1954

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Mice were administered substance by intraperitoneal injection daily for 5 days, at various doses, and toxicity was assessed.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS 1761-71-3 (cyclohexylamine,4'4-methylenebis-).
Material is a solid, approximately 50% trans-trans isomer

Test animals

Species:
mouse

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
5 days
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
25, 50, 100 mg/kg bw
Control animals:
not specified
Details on study design:
Test was performed as a range-finding study for dose selection for a test of antineoplasic effects of the substance. Five animals per group were used, doses tested were 25, 50 and 100 mg/kg bw. Test substance (in oil) was administered i.p.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Details on results:
- In the highest dose group, all animals died shortly after the first or second injection. In the mid-dose group, two animals died
- These animals showed marked body weight loss
- The animals of the lowest dose group showed no symptoms

Effect levels

Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion