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Key value for chemical safety assessment

Effects on fertility

Description of key information

Based on the results of the combined repeated dose and reproduction / developmental screening test with the read across substance, the test substance is not considered to be of reproductive and development toxicity concern.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Guideline compliant study
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A study was conducted to determine the toxicity to reproduction of the read across substance, mono- C12 PSE, Na+, according to OECD Guideline 422, in compliance with GLP. The test substance was administered at 0 (control group), 250, 500 or 1000 mg/kg bw to male Sprague-Dawley SPF rats for 14 days before mating, through the mating period, and up to 1 day before necropsy (42 days in total) and to female Sprague-Dawley SPF rats for 14 days before mating, through the mating period and the gestation period, up to day 4 of lactation (42 to 45 days in total) to investigate the repeated-dose, reproductive and developmental toxicities. In the 0 and 1000 mg/kg bw groups, a 14-day recovery period was allowed after the 42-day administration period to investigate the reversibility of the toxic changes. No test substance-related effects were observed regarding clinical signs, detailed clinical findings, function tests, grip strength, amount of spontaneous movement, body weights, food consumption, urinalysis (including water intake), hematology or blood chemistry parameters. Gross pathological examination at the end of the administration period revealed recessed areas in the forestomachs at 250 mg/kg bw and above and rough mucosa or white foci at 500 mg/kg bw and above, and erosion/ulceration, mucosal thickening and submucosal edema at 250 mg/kg bw and above on histopathological examination. In the light of the absence of a forestomach in humans, observed effects on this tissue were of questionable relevance with reference to the extrapolation of the toxic properties of a test substance in humans. Further, administration of the test substance did not have any effect on the estrous cycle, days to copulation, copulation rate, fertility rate, or conception rate. Similarly, administration of the test substance did not have any effect on the delivery rate, gestation period, number of corpora lutea, number of implantation sites, implantation rate, stillbirth rate, number of live-born pups, live-birth rate in the mother animals, or on the sex ratio of the littermates. No abnormalities were observed in the lactating behavior during the lactation period either. These results suggest that administration of the test substance even at 1000 mg/kg bw had no effect on the reproductive function, such as that shown by the copulation rate, of the males or females, or in the fertility rate, conception rate, or on the gestation maintenance, delivery, or lactating behavior in the mother animals. Pups showed no changes caused by the administration of the test substance regarding the observation at birth, necropsy findings on day 4 of lactation, body weight, or viability rate, which suggested that administration of the test substance even at 1000 mg/kg bw had no effect on the development. Based on the results of the read across study, the NOAEL for systemic effects and reproductive/development toxicity is considered to be at 1000 mg/kg bw/day (METI, 2005).

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of a combined repeated dose toxicity and reproductive/developmental screening study (OECD 422) with the read across substance, no classification is required for this endpoint according to CLP (Regulation 1272/2008/EC) criteria.​​

Additional information