Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No study data available. Endpoint subject to waiver request based on no effects on reproductive organs seen in repeat dose toxicity study - see EC 1907/2006, appendix IX, section 8.7.3


Short description of key information:
No study data available. Endpoint subject to waiver request based on no effects on reproductive organs seen in repeat dose toxicity study.

Justification for selection of Effect on fertility via oral route:
Endpoint subject to waiver request based on no effects on reproductive organs seen in repeat dose toxicity study.

Justification for selection of Effect on fertility via inhalation route:
Endpoint subject to waiver request based on no effects on reproductive organs seen in repeat dose toxicity study.

Justification for selection of Effect on fertility via dermal route:
Endpoint subject to waiver request based on no effects on reproductive organs seen in repeat dose toxicity study.

Effects on developmental toxicity

Description of key information
In a key read across developmental toxicity study (Elf Aquitaine, 1997; Klimisch score = 1), three groups of female Sprague-Dawley rats (25/dose) were orally administered (via gavage) di-tert-dodecyl polysulfide (TPS 32) at doses of 0, 50, 250, or 1000 mg/kg/day, each day from day 6 to day 15 post-coitum. 
No mortality or signs of adverse clinical toxicity were observed through the study period. No abortions or total resorptions were observed in females in any treatment group while food consumption and body weight gain of pregnant dams was comparable to the control animals. Macroscopic examinations did not reveal any significant difference between animals in the treatment and control groups and post-implantation losses were similar in the 0, 50, and 250 mg/kg/day dose groups. Incidence of late resorption was observed in one female in the 1000 mg/kg/day dose group but was not considered treatment-related. No treatment-related effects on the number of live fetuses per animal, fetal body weight, or fetal sex ratio were observed and no treatment-related external, soft tissue, or skeletal malformations were noted through the study period in any of the dose groups.
Based on the lack of significant adverse clinical effects observed, the maternal and developmental toxicity NOAELs were determined to be 1000 mg/kg/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No key developmental toxicity data were identified for di-tert-nonyl polysulfide. However, key read across data was available from di-tert-dodecyl polysulfide, a structural analog of di-tert-nonyl polysulfide.

In an OECD TG 414 study, three groups of 25 mated female rats received di-tert-dodecyl polysulfides (TPS 32), by oral gavage at the dose levels of 50, 250 or 1000 mg/kg/day, each day from day 6 to day 15 post-coitum inclusive. Simultaneously, a group of 25 mated females was given the vehicle alone (0.5% carboxymethylcellulose) under the same conditions and acted as a control group. Clinical signs including (including evidence of abortion/resorption) and mortality were checked daily. Food consumption and body weight were recorded at designated intervals during pregnancy. On day 20 post-coitum, females were killed. The gravid uterus was weighed and fetuses were removed by hysterectomy. Females were examined macroscopically. Litter parameters were recorded: number of corpora lutea, implantation sites, resorptions, dead and live fetuses. The live fetuses were weighed, sexed, submitted to an external examination and then to soft tissue or skeletal examinations.

No clinical signs and no unscheduled deaths were observed in any group. No females aborted or presented total resorption in any group. The food consumption and body weight gain of the pregnant females from all treated groups were similar to those of controls. No treatment-related macroscopic findings were observed, in any group.The post-implantation loss was similar in the 0, 50 and 250 mg/kg/day groups. In the 1000 mg/kg/day group, a slightly increased post-implantation loss (represented mainly by late resorptions, observed in one female) was observed: it could not be demonstrated that this single event was treatment-related. No treatment-related effects were observed on the number of live fetuses per animal, the fetal body weight or the sex-ratio. No treatment-related external, soft tissue and skeletal anomalies or malformations were observed in any group.

 

The No Effect Level is defined as 1000 mg/kg/day in terms of maternotoxicity, embryofetotoxicity and teratogenic effects.

Read across justification

Several criteria justify the use of the read across approach to fill data gaps for di-tert-nonyl polysulfide using di-tert-dodecyl polysulfide as an analog. Di-tert-nonyl polysulfide like di-tert-dodecyl polysulfide, is a polysulfide and has similar physiochemical properties. Hence, thetoxicological properties of both these substances are also expected to be similar.


Justification for selection of Effect on developmental toxicity: via oral route:
No effects observed in a well-conducted study on a structurally related analogue substance

Justification for classification or non-classification

The data available do not meet the criteria for classification for developmental toxicity under EU CLP - Regulation 1272/2008.