Registration Dossier
Registration Dossier
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EC number: 442-600-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Two guideline studies were performed to assess the irritating potential of HiTEC 7134 (skin and eye). According to the results of the studies the test substance is a moderate skin irritant but not an eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
One guideline (OECD 404) skin irritation study with H1734 is available, where 3 New Zealand white albino rabbits were used (Johnson IR (2001d)). Very slight, well-defined or moderate to severe erythema was seen in 2 out of the 3 animals for 7 days and 1 animal for 28 days post-application. Very slight, slight or moderate edema was observed in two animals up to 4 days after application. Additional signs of irritation such as desquamation, thickening, wrinkling, scabbing, bruising and areas of new skin were recorded during the conduction of this experiment. One animal showed signs of slight irritation of day 28 but was clearly recovering. Based on these results the test substance may be considered as a moderate skin irritant to the rabbit.
One guideline (OECD 405) eye irritation study with H7134 is available. Three rabbits were used, and an assessment of initial pain was performed (Johnson IR (2001c)). Instillation into the eye caused no initial pain (class 0 on a 5 -0 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in 2 animals for less than 48 hours and a slight discharge in all animals approximately 1 hour after instillation. Additional signs of irritation comprised convoluted or erythematous eyelids and dried secretion around periorbital skin. One animal still had convoluted eyelids at termination on day 3. Based on the results, the HiTEC 7134 is not an eye irritant.
No information is available on respiratory irritation.
Effects on skin irritation/corrosion: moderately irritating
Justification for classification or non-classification
Despite the fact that the mean scores obtained for skin erythrema and edema for two out of the three animals, were below 2.3 (limit for classification according to Regulation 1272/2008), the substance shall be classified as a skin irritant (Category II), due to persistence of other irritation symptoms (like desquamation) over the 14 day initial observation period.
The test substance does not need to be classified for eye irritationInformation 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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