Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Estimated NOAEL (reproductive toxicity)= 1 mg/kg bw/day based on the results of preliminary OECD TG 422.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Expert judgement.
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 preliminary  prenatal developmental toxicity study in rats treated with Tetraphosphorus trisulphide was performed to set the doses of the main study OECD TG 422. A high toxicity  causing the mortality of many treated animals was observed for all doses. The high toxicity of the substance in rats by oral route could not permit to evaluate the reproductive/developmental effects of the substance. Other routes of exposure are inappropriate. Based on the results of preliminary study OECD TG 422 , NOAEL (repeated oral toxicity 28 days rat)= 1 mg/kg bw/day was chosen to calculate DNEL value in precautionary way . The same NOAEL = 1 mg/kg bw/day is applied also for reproductive toxicity and the limit of exposure obtained for general population by oral route related to long-term exposure is the same of carcinogenic substance (TTC= 1.5 μg/kg bw/day). In this way the potential reproductive toxicity hazard is under control.

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

 According to the CLP Regulation (EC n.1272/2008), reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, adverse effects on development of the offspring and adverse effects on or via lactation. Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans. Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1.

The high toxicity of Tetraphosphorus trisulphide observed in the preliminary study OECD TG 422 by oral route could not permit to evaluate the reproductive/developmental effects of the substance. No classification is suggested for the reproductive toxicity of Tetraphosphorus trisulphide because the substance is already classified for repeated oral toxicity (H373) according to the CLP Regulation (EC n.1272/2008). Moreover, on precautionary principle NOAEL (reproductive toxicity)= 1 mg/kg bw/day is applied and the limit of exposure obtained for general population by oral route related to long-term exposure is the same of carcinogenic substance. (TTC= 1.5 μg/kg bw/day). In this way the potential reproductive hazard is under control.