Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
three-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no glp, equvalent or similar to giudeline
Justification for type of information:
In stomach dissociation of SnSO_4 into Sn^2+ and SO_4^2-. Read across to SnCl_2. No adverse effects of the different anions. Higher amounts of chloride and sulphate anions are part of daily nutrition than in the test compounds. So Sn(II) is responsible for effects.

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
Principles of method if other than guideline:
-
GLP compliance:
not specified
Limit test:
no
Justification for study design:
-

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
-

Test animals

Species:
rat
Strain:
other: CPB: WU randomly bred
Details on species / strain selection:
n.a.
Sex:
male/female
Details on test animals and environmental conditions:
n.a.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on exposure:
-
Details on mating procedure:
-
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
-
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: ppm Sn in diet
Remarks:
Doses / Concentrations:
0, 200, 400, 800 ppm
Basis:
other: Sn in diet
Dose / conc.:
200 other: ppm Sn in diet
Dose / conc.:
400 other: ppm Sn in diet
Dose / conc.:
800 other: ppm Sn in diet
No. of animals per sex per dose:
no data
Control animals:
yes
Details on study design:
-
Positive control:
-

Examinations

Parental animals: Observations and examinations:
-
Oestrous cyclicity (parental animals):
-
Sperm parameters (parental animals):
-
Litter observations:
-
Postmortem examinations (parental animals):
-
Postmortem examinations (offspring):
-
Statistics:
-
Reproductive indices:
-
Offspring viability indices:
-

Results and discussion

Results: P0 (first parental animals)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
-
Description (incidence and severity):
-
Mortality:
no mortality observed
Description (incidence):
-
Body weight and weight changes:
no effects observed
Description (incidence and severity):
-
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
-
Food efficiency:
no effects observed
Description (incidence and severity):
-
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
-
Ophthalmological findings:
no effects observed
Description (incidence and severity):
-
Haematological findings:
no effects observed
Description (incidence and severity):
-
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
-
Urinalysis findings:
no effects observed
Description (incidence and severity):
-
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
-
Immunological findings:
no effects observed
Description (incidence and severity):
-
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
-
Gross pathological findings:
no effects observed
Description (incidence and severity):
-
Neuropathological findings:
not examined
Description (incidence and severity):
-
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
-
Histopathological findings: neoplastic:
not examined
Description (incidence and severity):
-
Other effects:
no effects observed
Description (incidence and severity):
-

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Description (incidence and severity):
-
Reproductive function: sperm measures:
no effects observed
Description (incidence and severity):
-
Reproductive performance:
no effects observed
Description (incidence and severity):
-

Details on results (P0)

-

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
ca. 800 other: ppm Sn diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no effect reported
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (P0)

Key result
Critical effects observed:
no

Results: P1 (second parental generation)

General toxicity (P1)

Clinical signs:
no effects observed
Description (incidence and severity):
-
Description (incidence and severity):
-
Mortality:
no mortality observed
Description (incidence):
-
Body weight and weight changes:
no effects observed
Description (incidence and severity):
-
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
-
Food efficiency:
no effects observed
Description (incidence and severity):
-
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
-
Ophthalmological findings:
no effects observed
Description (incidence and severity):
-
Haematological findings:
no effects observed
Description (incidence and severity):
-
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
-
Urinalysis findings:
no effects observed
Description (incidence and severity):
-
Behaviour (functional findings):
no effects observed
Description (incidence and severity):
-
Immunological findings:
no effects observed
Description (incidence and severity):
-
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
-
Gross pathological findings:
no effects observed
Description (incidence and severity):
-
Neuropathological findings:
not examined
Description (incidence and severity):
-
Histopathological findings: non-neoplastic:
not examined
Description (incidence and severity):
-
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
-
Other effects:
no effects observed
Description (incidence and severity):
-
Details on results:
-

Reproductive function / performance (P1)

Reproductive function: oestrous cycle:
no effects observed
Description (incidence and severity):
-
Reproductive function: sperm measures:
no effects observed
Description (incidence and severity):
-
Reproductive performance:
no effects observed
Description (incidence and severity):
-

Details on results (P1)

-

Effect levels (P1)

Key result
Dose descriptor:
NOAEL
Effect level:
ca. 800 other: ppm Sn diet
Basis for effect level:
other: no effect
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (P1)

Key result
Critical effects observed:
no

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Description (incidence and severity):
-
Description (incidence and severity):
-
Mortality / viability:
no mortality observed
Description (incidence and severity):
-
Body weight and weight changes:
no effects observed
Description (incidence and severity):
-
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
-
Food efficiency:
no effects observed
Description (incidence and severity):
-
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
--
Ophthalmological findings:
not examined
Description (incidence and severity):
-
Haematological findings:
no effects observed
Description (incidence and severity):
-
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
-
Urinalysis findings:
no effects observed
Description (incidence and severity):
-
Sexual maturation:
no effects observed
Description (incidence and severity):
-
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
-
Gross pathological findings:
no effects observed
Description (incidence and severity):
-
Histopathological findings:
no effects observed
Description (incidence and severity):
-
Other effects:
no effects observed
Description (incidence and severity):
-

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not examined
Description (incidence and severity):
--

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not examined
Description (incidence and severity):
-

Details on results (F1)

-

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
ca. 800 other: ppm Sn in diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no effects observed
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (F1)

Key result
Critical effects observed:
no

Results: F2 generation

General toxicity (F2)

Clinical signs:
no effects observed
Description (incidence and severity):
-
Mortality / viability:
no mortality observed
Description (incidence and severity):
-
Body weight and weight changes:
no effects observed
Description (incidence and severity):
-
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
-
Food efficiency:
no effects observed
Description (incidence and severity):
-
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
-
Ophthalmological findings:
not examined
Description (incidence and severity):
-
Haematological findings:
no effects observed
Description (incidence and severity):
-
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
-
Urinalysis findings:
no effects observed
Description (incidence and severity):
-
Sexual maturation:
no effects observed
Description (incidence and severity):
-
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
-
Gross pathological findings:
no effects observed
Description (incidence and severity):
-
Histopathological findings:
no effects observed
Description (incidence and severity):
-
Other effects:
no effects observed
Description (incidence and severity):
-

Developmental neurotoxicity (F2)

Behaviour (functional findings):
not examined
Description (incidence and severity):
-

Developmental immunotoxicity (F2)

Developmental immunotoxicity:
not examined
Description (incidence and severity):
-

Details on results (F2)

-

Effect levels (F2)

Key result
Dose descriptor:
NOEL
Generation:
F2
Effect level:
> 800 ppm
Sex:
not specified
Basis for effect level:
other: no effect
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (F2)

Key result
Critical effects observed:
no

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
800 other: ppm Sn diet

Applicant's summary and conclusion

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