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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-061-8 | CAS number: 77-83-8
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion negative (EU B46); eye irritation negative (OECD 405).
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
In Harlan study No. 41104025, to OECD 439 and to GLP, an in vitro test, using Human Reconstructed Epidermis (RHE) model, the test substance was found to be negative for skin irritation. According to Commission Regulation EC No. 761/2009, amending Commission Regulation EC No. 440/2008 (Test Methods Regulation), this method, referred to as EU method B.46, "may allow determining the skin irritancy of substances as a stand-alone replacement test within a testing strategy, in a weight of evidence approach". Further in vivo testing for this endpoint can be discounted on animal welfare grounds, thus avoiding potential pain and suffering of animals.
In Haarman & Reimer study No. 01732 to OECD 405, and to GLP, in vivo eye irritation study, the substance was found to be not irritating to eyes. An in vitro eye irritation test was not required because of the existence of this in vivo study.
Justification for classification or non-classification
Skin irritation/corrosion
According to Regulation (EC) No. 1272/2008, sections 3.2.2.6 and 3.2.2.7, for skin irritation/corrosion substances can be classified as skin corrosive category 1, skin irritant category 2 or not classified. The substance was found to be non-irritant, and should therefore not be classified for skin irritation or corrosion.
Eye irritation
Regulation (EC) No. 1272/2008, sections 3.3.2.6. and 3.3.2.7 cover "Irreversible effects on the eye/serious damage to eyes (Category 1)" and "Reversible effects on the eye (Category 2) respectively". Haarman & Reimer (2000) found that the substance was not irritating to eyes, interpreting the data in accordance with Directive 93/21/EEC rather than the later Regulation EC No. 1272/2008. Re-interpretation of these data in accordance with the criteria laid out in Regulation (EC) No. 1272/2008 clearly show that the original conclusion is also consistent with that regulation. The substance should therefore not be classified with regards to eye irritation.
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.
