Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from collection of data.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
IARC Monographs on the evaluation of carcinogenic risks to humans. Cobalt and cobalt compounds.
Author:
International Agency for Research on Cancer
Year:
1991
Bibliographic source:
IARC 1991 52 363: 1017-1606
Reference Type:
publication
Title:
Does cobalt damage the hamster embryo? A preliminary report (Abstract).
Author:
Gale TF
Year:
1980
Bibliographic source:
Anat. Rec. 196: 232A

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Subcutaneous application of the test substance on GD8, determination of resorptions and effects on prenatal development of offspring on GD15.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): cobalt acetate
- Analytical purity: not reported

Test animals

Species:
hamster
Strain:
not specified

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
acute exposure on GD 8
Frequency of treatment:
single
Duration of test:
GD 8 to 15
Doses / concentrations
Remarks:
Doses / Concentrations:
40, 60, 80, 100, 160 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
not reported
Control animals:
not specified

Examinations

Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: No data
- Number of resorptions: Yes (not further specified)
Fetal examinations:
- Central nervous system examinations: Yes

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no data

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
central nervous system defects

Effect levels (fetuses)

Dose descriptor:
LOAEL
Effect level:
40 mg/kg bw (total dose)
Basis for effect level:
other: fetotoxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Foetal damage was detected on gestation day 15 in hamsters administered cobalt acetate (40, 60, 80, 100 or 160 mg/kg bw) subcutaneously on day 8 of pregnancy, The resorption rate ranged from 6% at the low dose to 100% at the high dose. Central nervous system defects were reported at the median doses. No information on maternal toxicity was reported.

Applicant's summary and conclusion