Registration Dossier
Registration Dossier
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EC number: 416-250-2 | CAS number: 84632-59-7
Endpoint summary
Administrative data
Description of key information
- Skin irritation/ corrosion: OECD TG 404 (Ciba-Geigy Ltd 1993b); not corrosive, not irritating to skin.
- Eye Irritation: OECD TG 405 ( rabbit, Ciba-Geigy Ltd 1993c); no serious eye damage, not irritating to the eye.
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 / corrosion
In the key study 3 albino rabbits were treated with 500 mg test substance for 4 hours under semiocclusive conditions according to OECD TG 404 (adopted 1992) and GLP regulations (Ciba-Geigy 1993c). No cutaneous reactions were observed in all animals during the study. One hour after patch removal in all animals and 24 hours after patch removal in animals No. 529 and No. 471 a possible erythema reaction could not be evaluated because of orange staining (substance-related). Because no reactions were observed at 24 hours to 72 hours (animal No. 527) and at 48 hours to72 hours (animals No. 529 and No. 471) after removing the bandages, the test was ended after the 72 hours evaluation. In conclusion, the test substance is not irritant to skin.
Eye irritation
In the key study three albino rabbits were treated with 100 mg test substance for 24 h (rinsing with warm tap water) and were observed at 1, 24, 48, and 72 hours after application (Ciba-Geigy Ltd 1993c). The study was performed according OECD TG 405 (adopted 1987) and GLP regulations. A slight conjunctivitis was observed in 2 animals 24 h after application (conjunctivae redness of grade 1) and was fully reversible within 48 h. No other findings were observed at any time point and in any animal. Mean values (over 24, 48, and 72 h) were 0.2 (conjunctivae redness) and 0 (cornea, iris, chemosis), respectively. In conclusion, the test substance was not irritant to the eyes.
Respiratory irritation:
There exists no standard test method for the assessment of respiratory irritation. Thus, findings for skin/eye irritation and sensitisation were reviewed. No evidence for respiratory irritation was available from these studies.
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 substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
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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 substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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