Registration Dossier
Registration Dossier
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EC number: 221-435-4 | CAS number: 3091-25-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
The key study was chosen on the basis that it is a reliable OECD guideline study, performed to GLP.
No statistically significant differences were observed in the number of pregnant females, number of males that became sires, female fecundity index and the male and female fertility indices.
In conclusion, impared fertility was not observed at any dosage group.
Short description of key information:
Toxicity to reproduction: 001, Fertility was not impared at any dose levels of trichlorooctylstannane.
Effects on developmental toxicity
Description of key information
Toxicity to reproduction: 001, The gestation index was decreased in the highest dosage group, as were the number of females with liveborn pups. In the highest dosage group, 2 females with all stillborn pups was observed, an effect not seen in any other groups. The number of females with stillborn pups was statistically significantly increased in the highest dosage group. The live live birth index in the highest dosage group was only 74 % of that of the control. Post implantation loss was statistically significantly increased in the highest dosage group.
Macroscopic observation of the stillborn pups revealed no abnormalities of the pups. Four stillborn pups of the 500 mg/kg group were (partly) cannibalized; as far as possible no abnormalities were observed in these pups.
Based on the incidences in several parameters which together are considered post-impantation losses at the 500 mg/kg dose, the mid-dose level of 100 mg Trichlorooctylstannane/kg (equivalent to 6.4 mg/kg bw day in males and 4.8 - 7.7 mg/kg bw day for females) is judged to be the NOAEL for reproductive effects.
Additional information
The key study was chosen on the basis that it is a reliable OECD guideline study, performed to GLP and is considered to be reilablity 1.
Justification for classification or non-classification
No statistically significant fertility effects were observed and therefore no classification will be required.
Statistically significant reproduction/developmental effects were seen. These effects are independant of any other dose related toxicological effects and therefore classification will be required. In accordance with the DSD, 67/548/EEC, trichlorooctylstannane is classified as Cat. 3 repro: Xn; R63. In accordance with the CLP, 1272/2008, trichlorooctylstannane is classified as a category 2 reproductive toxicant with the signal word warning and hazard phrase H361.
Additional information
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