Registration Dossier
Registration Dossier
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EC number: 603-525-9 | CAS number: 131860-97-4
Endpoint summary
Administrative data
Description of key information
Eye irritation: Mild irritant, average scores day 1-3: cornea 0, iris 0, erythema 0.45, chemosis 0.22 (Robinson)
Skin irritation: no skin irritation was noted in acute dermal toxicity (cf. 7.2.3), hence according to Regulation (EC) 1907/2006, Annex VII and VIII, 8.1, column 2, in vitro and in vivo skin irritation testing is not required.
Respiratory irritation: slight signs of irritation noted in acute inhalation toxicity (cf. 7.2.2)
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
Eye
For this endpoint the summarised result of one study (Robinson) is available, which was conducted under GLP. While the full study report is not available, the results are sufficiently detailed and unambiguous as to be suitable for classification and labeling. Average scores (day 1-3): cornea 0, iris 0, erythema 0.45, chemosis 0.22.
Based on the given scores the assessment “not irritating” is carried forward for classification and labeling.
Skin
No skin irritation was noted in a limit-dose acute dermal toxicity study (see 7.2.3). Hence, according to Regulation (EC) 1907/2006, Annex VII and VIII, 8.1, column 2, in vitro and in vivo skin irritation testing is not required.
Respiratory
Slight transient respiratory irritant effects were noted in 2/3 males and 0/3 females in a 1-hour acute inhalation toxicity study (see 7.2.2). Because the study was performed with a maximum concentration < 5 mg/L, and extrapolated from 1-hour exposure data, the result is not considered to be conclusive for classification and labeling.
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
The available data on Eye Irritation is considered reliable and suitable for classification and labeling.
Based on the result, the substance does not meet the criteria for classification under the Directive 2001/59/EC, Annex VI, 3.2.6.2. as well as the criteria in the Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.3.2.
The available information on Acute Dermal Toxicity are considered reliable for the classification and labeling of the substance in term of Skin Corrosion/Irritation.
Based on the result, the substance does not meet the criteria for classification under the Directive 2001/59/EC, Annex VI, 3.2.6.1. as well as the criteria in the Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2.
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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