Registration Dossier

Administrative data

Description of key information

The substance appeared to be irritating, but not corrosive, to the skin; while the test substance is not irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Sulfur was examined for acute dermal irritating/corrosive properties in an experiment with six albino NZW rabbits, in compliance with OECD guideline 404 and under GLP (TNO, 1994). The test material (0.5 g) was mixed with vaselinum album (0.5 g) and applied under semi-occlusive conditions for 4 hours. Skin irritation scores were recorded using Draize criteria at 1, 24, 48 and 72 hours and at 7 days after removal of the test material. Irritation was initially absent, however 24 hr after patch removal moderate to severe erythema (grade 3) and slight oedema (grade 2) had developed in all animals, and was decreased only slightly at the 48 hr and 72 hr observation periods. Mean erythema and oedema scores of 2.67 and 1.57, respectively, were calculated for all animals taking into account responses at 24, 48 and 72 hr, however all skin effects had resolved completely by day 7. On the basis of these results, it is concluded that sulfur is irritating, but not corrosive, to rabbit skin.

Eye irritation

In a study in compliance with OECD guideline 405 eye irritation study (Rallis Research Centre, 2005), 84 mg (equivalent to 0.1 ml) of sulfur dust was instilled into the conjunctival sac of the left eye of three male NZW rabbits. The degree of irritation/corrosion was evaluated and scored at 1, 24, 48 and 72 hours post-instillation. The mean (24, 48 and 72 hrs) conjunctivae and chemosis scores were 0.44 and 0.28, respectively (the effects were fully reversible within 72 hours). Discharge (score 1 to 2) was observed at 1, 24 and 48 hours post instillation. There was no corneal and iris reaction.

In a second study in compliance with OECD guideline 405 and under GLP sulfur was examined for acute eye irritation/corrosive properties in an experiment with six albino NZW rabbits (TNO 1994). An amount of 0.1 g of the test substance was instilled in the conjunctival cul-de-sac of the right eye of six rabbits. The reactions of the test eyes were judged at 1, 24, 48 and 72 hours and at 7 days after treatment. The mean (24, 48 and 72 hours) cornea, iris, conjunctivae and chemosis scores were 0, 0, 0.61 and 0.06, respectively. At 72 hours after treatment, the eye effects had cleared in five rabbits, whereas the eye effects had cleared at 7 days in the sixth rabbit.

Justification for selection of skin irritation / corrosion endpoint:

Only available study.

Justification for selection of eye irritation endpoint:

One of two available studies.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available data, sulfur is classified for skin irritation (H315) In accordance with the EU CLP Regulation (EC No. 1272/2008).

Regarding eye irritation, based on the results of the available studies, sulfur does not need to be classified.