Registration Dossier

Administrative data

Description of key information

One key study was identified to evaulate the skin and eye irritation potential of di-tert-nonyl polysulfide. Based on the lack of adverse effects observed in rabbits, di-tert-nonyl sulfide is not considered to be a skin or ocular irritant. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin Irritation

 

One key study in rabbits was identified to evaluate the dermal irritation potential of di-tert-nonyl polysulfide. 

 

In a key primary dermal irritation study (Gonnet and Guillot, 1979; Klimisch score = 2), six male white rabbits were dermally exposed to 0.5 mL di-tert-nonyl polysulfide (TPS 37) for 23 hours and observed for a period of 72 hours post-exposure. Pads containing TPS 37 were placed on the skin covering the right flank, which had been scarified, and to the left flank, which was still intact. After 23 hours, the skin patches were removed and erythematous lesions were noted. At 24 hours, very slight to well-defined erythema that persisted through 72 hours was observed in 5 of 6 rabbits (mean erythema score = 1.67). Very slight oedema was observed in one animal at 24 hours and this persisted through 72 hours (mean oedema score = 0.167). All other animals appeared normal through the study period. The study authors concluded that di-tert-nonyl polysulfide was slightly irritating to the skin based on a primary irritation index of 1.88.

Eye Irritation

One key study in rabbits was identified to evaluate the ocular irritation potential of di-tert-nonyl polysulfide

In a key eye irritation study (Gonnet and Guillot, 1979; Klimisch score = 2), six male albino rabbits were exposed to 0.1mL of di-tert-nonyl polysulfide in the right eye. The left eye served as a control and observations were conducted at 1hour, 24hours, 48 hours,72 hours,and on days 4and 7 post-exposure. Scores for anomalies in the conjunctiva, alternations in pupil or iris, degree and extent of opacity of the cornea, and any ulceration or granulation of the cornea were scored and recorded for each animalateach observation point. 

 

The study authors calculated the index of acute ocular irritation to be 14.67 after one hour of test substance administration. The index of ocular irritation after 48 hours was 5.17. The mean conjunctiva, iris and cornea scores were determined to be 0.5, 0.61, and 0, respectively. All effects were fully reversible in 4 days for the iris and in 7 days for the conjunctiva. Based on these results,di-tert-nonyl sulfide is not considered to be an ocular irritant.

Respiratory Irritation

This data is not available.

Justification for classification or non-classification

Di-tert-nonyl polysulfide does not meet the criteria for classification and labelling as a skin irritant under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.

Di-tert-nonyl polysulfide does not meet the criteria for classification and labelling as an eye irritant as defined by EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.