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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
three-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This information is from the Concise International Chemical Assessment Document for Tin and Inorganic Tin Compounds which was issued by World Health Organization, but no details for the test procedure. Various animal data on inorganic compounds indicate even lower toxicity of Tin (IV) than Tin (II) and insoluble inorganic tin than soluble inorganic tin. Both Tin (II) oxide and Tin (IV) dioxide didn’t induce any effect in rats in repeated dose toxicity studies. Based on above, the use of Tin (II) oxide, Tin (IV) chloride, Tin (II) fluoride and Tin (II) chloride, as well as other stannic or stannous compounds as a structural surrogate for Tin (IV) dioxide (CAS No. 18282-26-4) for reproductive toxicity study is feasible.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In a multigeneration study, CPB:WU rats were given tin in the diet at 0, 200, 400, or 800 mg/kg for three generations to investigate the reproductive and developmental toxicity for Tin (as Tin(II) chloride).
GLP compliance:
not specified
Remarks:
Secondary source without such information
Limit test:
no

Test material

Constituent 1
Reference substance name:
tin(II) chloride
IUPAC Name:
tin(II) chloride
Details on test material:
No data

Test animals

Species:
rat
Strain:
other: CPB:WU
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on exposure:
CPB:WU rats were given tin in the diet at 0, 200, 400, or 800 mg/kg for three generations.
Details on mating procedure:
No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
three generations
No detailed information for accurate exposure duration
Frequency of treatment:
no data
Details on study schedule:
No data
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
200 mg/kg
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
400 mg/kg
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
800 mg/kg
Basis:
nominal in diet
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent no treatment
Details on study design:
No data
Positive control:
no data

Examinations

Parental animals: Observations and examinations:
Yes, growth of the parents and fertility were examined during the test.
Oestrous cyclicity (parental animals):
No data
Sperm parameters (parental animals):
no data
Litter observations:
numbers of offspring per litter and birth weight were observed.
Postmortem examinations (parental animals):
no data
Postmortem examinations (offspring):
Yes, F3b and F3c generations;
Statistics:
No data
Reproductive indices:
No data
Offspring viability indices:
No data

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed

Details on results (P0)

Tin did not affect growth of the parents, fertility, numbers of offspring per litter, or birth weight.

Effect levels (P0)

Dose descriptor:
NOAEC
Effect level:
800 mg/kg diet
Based on:
test mat.
Sex:
male/female

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings:
not specified

Details on results (F1)

In the study, tin did not affect numbers of offspring per litter or birth weight. Increased mortality of F2 ofspring during the first half of lactation was corrected by increasing the iron content of the mothers’ diet. Tin reduced offspring growth and haemoglobin levels during lactation but not thereafter. On pathological examination
of rats from the F3b and F3c generations, the F3b pups showed microscopic changes in the liver and spleen at weaning but not at 4 weeks of age. Within this multigeneration study, a teratogenicity tudy was carried out using 20 F2b females per dose level. On visceral and skeletal examination, there was no increase in the incidence of fetal malformations

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOAEC
Generation:
F2b
Effect level:
800 mg/kg diet
Based on:
test mat.
Sex:
female
Basis for effect level:
other: On visceral and skeletal examination, there was no increase in the incidence of foetal malformations.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
It can be concluded that, under test conditions, tIn II did not affect growth of the parents, fertility, numbers of offspring per litter, or birth weight of fetuses. Furthermore, there was no increase in the incidence of fetal malformations by test material.
Executive summary:

In a multigeneration study, CPB:WU rats were given tin in the diet at 0, 200, 400, or 800 mg/kg for three generations. To simulate the “form of the tin likely to be found in canned food,” tin(II) chloride was allowed to react in aqueous medium with the casein content of the diet. Tin did not affect growth of the parents, fertility, numbers of offspring per litter, or birth weight. Tin did not affect numbers of offspring per litter or birth weight. Increased mortality of F2 offspring during the first half of lactation was corrected by increasing the iron content of the mothers’ diet. Tin reduced offspring growth and haemoglobin levels during lactation but not thereafter. On pathological examination of rats from the F3b and F3c generations, the F3b pups showed microscopic changes in the liver and spleen at weaning but not at 4 weeks of age. Within this multigeneration study, a teratogenicity study was carried out using 20 F2b females per dose level. On visceral and skeletal examination, there was no increase in the incidence of fetal malformations.