Registration Dossier
Registration Dossier
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EC number: 449-360-4 | CAS number: 647828-16-8
Endpoint summary
Administrative data
Description of key information
- Skin irritation (in vivo): not irritating
(OECD TG 404, GLP).
- Eye irritation (in vivo): not irritating (OECD TG 405, GLP).
- Respiratory irritation: not irritating because the test substance is
not skin and 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:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation
An in vivo skin irritation test was performed in accordance with OECD TG 404 and under GLP-conditions to assess the irritancy potential of the test substance to the skin of the New Zealand White rabbit. A single 4-hour, semi-occluded application of the test substance to the intact skin of 3 rabbits produced well-defined erythema and slight oedema. These reactions scored maximally score 2 (Draize) and extended beyond all treated skin sites at the 24, 48 and 72-hour observations but were reversible within 14 days. Light brown discolouration, loss of skin elasticity and severe desquamation were also noted but no corrosive effects. The test substance is not considered a skin irritant.
Eye Irritation
An in vivo eye irritation study in accordance with OECD TG 405 and under GLP conditions was performed to assess the irritant potential of the test substances to the eye of the New Zealand White rabbit. A single application of the test substance to the non-irrigated eye of 3 rabbits produced slight conjunctival irritation with maximum average score of 0.33. All treated eyes appeared normal at the 48-hour observation. The test substance is not considered an eye irritant.
Respiratory Irritation
For respiratory irritation mostly human data are used for the assessment because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (ECHA guidance R.7.2.12.1, 2017). There are no human data that indicate respiratory reactions of the test substance e.g. from consumer experience or occupational exposure (ECHA guidance 7.2.12.2., 2017). The test substance is not skin and eye irritating and therefore the test substance is not considered to be a respiratory irritant (REACH guidance: 7.2.12.1).
Justification for classification or non-classification
The substance does not have to be classified for skin, eye and respiratory irritation according to EU CLP (EC No. 1272/2008 and its amendments).
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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