Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-781-5 | CAS number: 68608-26-4
Endpoint summary
Administrative data
Description of key information
The irritation potential has been assessed to the skin and eye of rabbits
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)
Additional information
All skin irritation data available demonstrate that the substance tested was not irritant to the skin.
In an ex-vivo chicken enucleated eye the substance tested caused severe loosening of the epithelium and the study terminated after the 30 minute observation period.
Two in vivo eye irritation studies demonstrate reactions that are considered of sufficient severity to regard the test samples as irritant to the eye, generally due to corneal effects. The effects were generally reversible and of sufficient severity to consider the substances to be irritating but not corrosive.
The remaining eye irritation studies produced low levels of background irritation that were of sufficient severity to regard the test substances as not irritating to eyes under the conditions of the tests.
Effects on eye irritation: irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Based on the data available for skin irritation the substance is considered to be not irritating to the skin.
The data available following exposure to eyes does, however, raise some cause for concern with regard to the substance. The only in vitro/ ex vivo study available resulted in the tests substance being considered corrosive. Such studies are, however, generally considered to be adequate for screening purposes only and are not adequate to distinguish between irritation and corrosivity. The conclusion of this report has not been demonstrated in any of the available in vivo studies available.
Two in vivo studies gave cause for concern that this category of substance has the potential to be irritating to eyes while four in vivo tests suggest that the category of substance is not irritating to eyes.
Although there is a weight of evidence to suppose that this category of substance may not be irritating to eyes, the results from two in vivo and one in vitro study is considered statistically significant and that the precautionary principle for hazard assessment should be applied in this case.
It is, therefore, considered most appropriate that the substance should be classified as irritating to eyes with the label R36, Irritating to eyes.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
