Registration Dossier

Toxicological information

Toxicity to reproduction: other studies

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study; not available for review
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Reproductive endpoints in general toxicity studies: are they predictive?
Author:
Chapin RE et al.
Year:
1998
Bibliographic source:
Reproductive Toxicology 12, 489-494
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Principles of method if other than guideline:
Type: other: subchronic
Method: other: determination of sperm motility and concentration in males and length of oestrus cycle and vaginal cytology following repeated dose according EPA OPP 82-1
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: o-cresol purity > 99 %

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
90 d
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1250, 5000 ppm
Basis:

Control animals:
yes, concurrent no treatment
Details on study design:
Duration of test: 90

Results and discussion

Any other information on results incl. tables

RS-Freetext:

 

Male:

Reproductive organ weights (R. testicle and R. epididymidis) showed no difference to the respective controls; epididymal tail weight was significantly reduced when compared to the respective control.

Spermatogonial measurements revealed no findings.

 

Female:

Mean estrous cycle length was significantly prolonged at 20000 ppm.

Applicant's summary and conclusion