Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
non skin irritant
eye 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:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The eye and skin irritation of the substance are evaluated by considering data on Similar Substances in a weight of evidence approach. Justification for Read Across is given in Section 13 of IUCLID.
Skin irritation
The skin irritation on similar substances are evaluated in in vitro systems and also in an in vivo study.
The tissue viability determined in the in vitro studies was above the threshold for classification of the substance as a skin irritant or skin corrosive.
The skin irritation/corrosion potential of the similar substance was evaluated also in vivo. The substance was applied on the shaved skin of six Newzeland albino rabbit in an occlusive coverage. Based on the scores of erythema and edema, the test material does not present any signs of irritation.
The test substance is therefore not considered as a skin irritant.
Eye irritation
The eye irritation of the substances was evaluated in in vivo studies and also in an in vitro / ex vivo studies.
The in vivo study (1984) identifies the test material as an eye irritant based on the scores of cornea, conjuctivae redness and conjuctivae chemosis. The other two in vivo studies could not be used for classification assessment since only two animals were tested; no eye irritation was observed in cornea and iris, slight irritation was observed in conuctivae (redness and chemosis).
The ocular irritancy potential of the test material was assessed after application onto the cornea of an enucleated rabbit eye in three other studies. The %corneal swelling suggested that the test materials are unlikely to have the potential to cause severe ocular irritancy in vivo.
Following a conservative approach and considering the results of the in vivo study (1984) the substance is considered as an eye irritant.
Justification for classification or non-classification
Based on the available studies the substance should not be classified for skin irritation but should be classified as an Eye Irritant (Cat.2) -H319 according to the CLP Regulation (EC) No. 1272/2008.
Furthermore, a component of the UVCB substance classified as Skin Corr. 1B (H314) is in a percentage that does not allow the classification of the UVCB substance in the same category.
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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