Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
combined repeated dose and carcinogenicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
RTECS Number : BZ7175000; Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and Occupational Diseases.
Year:
2012
Bibliographic source:
RTECS (Registry of Toxic Effects of Chemical Substances);V.1-36, 1957-1992. MTPEEI Volume(issue)/page/year: 32(3),48,1988

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
RTECS database
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
30D
Frequency of treatment:
intermittent

Results and discussion

Results of examinations

Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Liver - liver function tests impaired Liver - changes in liver weight Blood - other changes

Effect levels

Dose descriptor:
other: TDLo
Effect level:
13 500 other: mg/kg/30D
Based on:
test mat.
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion