Registration Dossier

Administrative data

Description of key information

Not irritating on rabbit skin (OECD 404)
Not irritating in rabbit eyes (OECD 405)

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 study available

Additional information

Reliable data have been obtained on skin and eye irritation of two members of the category of derivatives of 4,4’-bis(1,3,5-triazinyl-2-yl)amino)stilbene-2,2’-disulfonic acid, each with one anilino and one alkyl amino moiety: EC 476-900-6 and EC 416-640-2. Both substances were found to be not irritating. In supporting studies on skin and eye irritation with EC 240-521-2 the conclusion was made, that the substance is not irritating. Therefore, it is concluded that the substance defined in section1 is not irritating to skin and eyes.

 

EC 476-900-6:
The skin irritation potential of the test substance was investigated according to OECD 404. The test substance (0.5g) was applied topical by semi-occlusive conditions for 4 hours to 3 adult New Zealand White rabbits. The application resulted in mild signs of irritation. These effects were reversible and no longer evident 7 days after treatment. The score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal). The mean erythema/eschar score of the three animals was 0.67, 1.00 and 1.33, respectively and the mean oedema score was 0.00 for all three animals, respectively. Thus the test item did not induce significant or irreversible damage to the skin.

The eye irritation potential of the test substance was investigated according to OECD 405. The test substance (0.1g) was applied into the left eye of three young adult New Zealand White rabbits. The score was calculated across 3 scoring times (24, 48 and 72 hours after application). The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.33 for all three animals, respectively. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus the test item did not induce significant or irreversible damage to the rabbit eye.

 

EC 416-640-2:
The skin irritation potential of the test substance was investigated according to OECD 404. The test substance (0.5g) was applied topical by semi-occlusive conditions for 4 hours to 3 adult New Zealand White rabbits. Very slight erythema was noted at two test sites at the 1-hur observation. All animals appeared normal 24 hours after treatment. Thus the test item did not induce significant or irreversible damage to the skin. The test material produced a primary irritation index of 0.0.

 

The eye irritation potential of the test substance was investigated according to OECD 405. The test substance (81 mg) was applied into the left eye of three young adult New Zealand White rabbits. Transient iridial inflammation was noted in all treated eyes at the 1-hour observation. Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal conjunctival irritation at the 24-hour observation and two treated eyes had minimal conjunctival irritation at the 48-hour observation. All animals had recovered by the 72-hour observation. The test material did not produce positive criteria in any rabbit according to the EC labelling regulation.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for skin and eye irritation/corrosion under Regulation (EC) No. 1272/2008.