Registration Dossier
Registration Dossier
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EC number: 237-158-7 | CAS number: 13674-84-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There is no study available so far.
Additional information
In a two-generation reproductive toxicity study with TCPP, there were no treatment related effects in pre-coital time, mating index, female fecundity index, male and female fertility index, duration of gestation and post-implantation loss. There was no effect on sperm parameters at necropsy. In females, the length of the longest oestrus cycle and the mean number of cycles per animal were statistically significantly increased in high dose animals of both generations. A decrease in uterus weight was observed in all dosed females in F0 and in high dose females in F1. Effects were also noted on pituitary weights, significant in high dose females of both generations. A LOAEL of 99 mg/kg is derived for effects on fertility. This is based on effects on the effect on uterus weight seen in all dosed females in F0 and high dose females in F1.
Existing data support the assumption that TCPP does not present a reproductive concern. There were no gross or histopathological changes noted in the reproductive organs of males or females in a 3-month dietary study conducted in rats at dose levels ranging from 800-20,000 ppm. In addition, genetic toxicity data suggest that the chemical is non-genotoxic.
Short description of key information:
LOEAL=99 mg/kg for rat, according to OECD TG 416
Effects on developmental toxicity
Description of key information
LOAEL=99 mg/kg for rat, according to OECD TG 416.
Additional information
Based on the result of the prenatal which indicated no treatment-related effects on foetal mortality, implantation number, resorption or foetal weight were observed following treatment of pregnant dams with TCPP. Cervical ribs and missing 13th ribs were noted at a low incidence in all treatment groups, but not in the control group. However,as a specific rib count undertaken in the 2-generation study did not reveal an increase in this effect, it is concluded that this is not toxicologically significant. Weaning rate and rearing condition were unaffected by treatment and there was no evidence of any abnormality.
Therefore, the TCPP is not expected to be a developmental toxin.
Toxicity to reproduction: other studies
Additional information
There is no study available so far.
Justification for classification or non-classification
Base on the test result from 3-month dietary study and two-generation reproductive toxicity study which conducted in rats, no gross or histopathological changes were noted in the reproductive organs of the males or females. In a developmental toxicity study conducted in rats, no teratogenic effects were observed. Based on the results of these studies and the data suggesting that the chemical is non-genotoxic, it is not expected to be a reproductive or developmental concern. Therefore, No classification for the TCPP is proposed in the reproductive and developmental toxicity and no further testing is necessary.
Additional information
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