Registration Dossier

Administrative data

Endpoint:
three-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no glp, equvalent or similar to giudeline
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Reference
Reference Type:
review article or handbook
Title:
Tin and stannous chloride
Author:
WHO
Year:
1982
Bibliographic source:
WHO Food Additives Series 17

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
Deviations:
not specified
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CPB: WU randomly bred
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 200, 400, 800 ppm
Basis:
other: Sn in diet
No. of animals per sex per dose:
no data
Control animals:
yes

Results and discussion

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOEL
Generation:
F2b
Effect level:
> 800 ppm
Sex:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No teratogenic effects. The growth of the parent rats was not adversely affected in any
generation.