Phenol, 2,4-dinitro-, sulfurized, leuco derivatives

Endpoint summary

Description of key information

Leuco Sulfur Black 1 caused none to very mild signs of skin or eye irritation in the rat or rabbit, respectively, without any relevance for classification and labelling.

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

The skin irritation potential of Leuco Sulphur Black 1 was assessed in the acute dermal toxicity study according to OECD Guideline 402 under GLP.

Five male and five female rats were treated at 2319 mg active ingredient/kg (corresponding to 4396 mg test item / kg bw) by dermal application. The test item was formulated in purified water and administered at a volume dosage of 6 mL/kg. The application period was 24 hours.

No deaths occurred during the study. No clinical signs were observed during the course of the study.

Due to moderate black staining of the treated skin after the removal of the application patch, the assessment of erythema was first prevented on test day 2 in all animals. From test day 3 to test day 7 at the latest, a slight black staining was still present. Erythema was assessable, but not noted in all animals from test day 3 to the end of the study. No oedema was observed throughout the whole observation period. Scaling was observed in one male on test day 4.

 

The primary eye irritation potential of Leuco Sulphur Black 1 was investigated according to OECD test guideline No. 405 and GLP. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for all three animals for the conjunctival reddening and swelling were 0.00 and 0.00, respectively.

The instillation of Leuco Sulfur Black 1 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening and swelling of the conjunctivae, redness of the sclera as well as discharge. These effects were reversible and were no longer evident 24 hours after treatment in all animals. Black test item remnants were observed in the eye or conjunctival sac of all three animals at the 1-hour reading. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Based on the lacking skin and eye irritation potential, the high boiling point and consequently very low vapro pressure, a respiratory irritation can be excluded.

Justification for classification or non-classification

Based on the available data Leuco Sulfur Black 1 is not subject to classification and labelling according to Directive 67/548/EEC and Regulation 1272/2008/EC.