Registration Dossier
Registration Dossier
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EC number: 482-330-9 | CAS number: 144020-22-4
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion (in vivo): the substance does not cause skin irritation/corrosion (OECD TG 404).
Eye corrosion/irritation (in vivo): the substance is not an eye irritant (OECD TG 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation/corrosion
Skin irritation potential of the substance was carried out according to OECD TG 404 and GLP. Three rabbits received a single four-hour, semi-occlusive, dermal administration of approximately 0.5 mL of the test substance as supplied and were observed for 15 days. There was no sign of toxicity or ill health in any rabbit during the observation period. Very slight or well-defined erythema was evident in all animals throughout the first 72 hours after bandage removal and in one case on Day 8. Exfoliation was present in all animals seven days after bandage removal persisting in one case one week later. Based on the results of this study, the substance is not a skin irritant.
Eye irritation/corrosion
The eye irritating potential of the substance was determined in an eye irritation study (in vivo) performed according to OECD guideline 405 and under GLP conditions. Three rabbits were each administered a single ocular dose of a volume of 0.1 ml of the test substance and observed for four days after instillation. Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance with or without very slight chemosis and slight or moderate discharge was apparent in all animals throughout the first 48 hours after instillation. Instillation of the test substance gave rise to a slight initial pain response in one animal. The treated eye of each animal was overtly normal 72 hours after instillation. The results showed that the substance is not considered irritating.
Respiratory irritation
There are no occupational or consumer data indicating respiratory tract irritation. There are also no relevant experimental guidelines or results available that indicate respiratory irritation, therefore respiratory irritation is not anticipated. The ECHA guidance presents (R7a: 7.2.12.1, 2017) that respiratory irritation may be indicated when the substance is a severe irritant. The substance is not a skin or eye irritant and therefore it is not considered a respiratory irritant.
Justification for classification or non-classification
The substance does not have to be classified for skin irritation/corrosion, eye irritation/corrosion or respiratory irritation according to EU CLP (EC No. 1272/2008 and its amendments).
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