Registration Dossier
Registration Dossier
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EC number: 202-940-9 | CAS number: 101-41-7
Endpoint summary
Administrative data
Description of key information
Skin irritation: The potential of the test item to cause skin irritation was determined in one in vitro study according to OECD guideline 439, and one human patch test. No skin irritation potential was observed.
Eye Irritation: The potential of the test item to cause eye irritation was tested in a study according to OECD guideline 405. The test item causes no eye irritation.
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
Skin Irritation
Key
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. The test item was tested in a purity of 99.9 %. Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes. After treatment with the test item the mean relative absorbance value was reduced irrelevantly to 78.2% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
Conclusion: The in-vitro key study was performed according to OECD guideline 439. No skin irritation effects were observed in this study. In conclusion it can be stated that the test substance is not skin irritating.
Eye Irritation
The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405. Four female albino rabbits were exposed to 0.1 mL of the test article, applicated undiluted in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:
Cornea: 0 (all animals)
Iris: 0 (all animals)
Conjunctiva: 0.33, 0, 0.67, 0.33
Chemosis: 0.33, 0, 0, 0
All results were fully reversible. In conclusion the test item causes no eye irritation.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation and eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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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