Registration Dossier
Registration Dossier
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EC number: 416-210-4 | CAS number: 128119-70-0
Endpoint summary
Administrative data
Description of key information
Skin irritation (in vivo): non-irritating (EU Method B.4)
Eye irritation (in vivo): irritating with serious damage (OECD TG 405)
Respiratory irritation: not irritating
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
A study according to EU Method B.4 was performed to assess the skin irritation potential of Bornafix to the rabbit. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for a maximum of nine days. A single semi-occlusive application of Bornafix to intact rabbit skin for four hours elicited well defined dermal reactions. Erythema scores were 1.667, 1.667, and 2 and edema scores were 1, 1, 1.667 for the three rabbits, respectively. All reactions had resolved by Day 8 or 9. Bornafix is non-irritant to rabbit skin.
Eye irritation
A study according to OECD 405 was performed to assess the eye irritation potential of Bornafix to the rabbit. Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for a maximum of 21 days after instillation. A single instillation of Bornafix into the eye of the rabbit elicited corneal opacification, iridial inflammation and well-defined to moderate conjunctival reactions. All reactions had resolved 7, 14 or 21 days after instillation. It is concluded that Bornafix is irritant with serious damage to the rabbit eye.
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 (REACH guidance R.7.2.3). There are no human data such as indicated in R7.2.3 of the ECHA guidance that indicate respiratory reactions of the substance e. g. from consumer experience or occupational exposure. Despite the eye irritation potential, the substance is not corrosive or severely irritating which further minimizes the respiratory irritation hazard (REACH guidance R7.2.1.2). The substance also has a low vapour pressure (0.67 Pa), which minimises the exposure via the inhalation route.
Justification for classification or non-classification
The substance does not have to be classified for Skin irritation according to EU CLP (EC No. 1272/2008 and its amendments).
The substance has to be classified as Eye irritant Cat 2 and shall be labelled with H319: Causes serious eye irritation according to EU CLP (EC No. 1272/2008 and its amendments).
The substance does not have to be classified for 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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