Registration Dossier
Registration Dossier
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EC number: 303-085-5 | CAS number: 94158-14-2
Endpoint summary
Administrative data
Description of key information
key information on eye irritation:
One in vivo study (no guideline and no information about GLP): 0.1 ml of a 2 % (corresponds to 2 mg test substance) test solution in water was tested in 10 female guinea pig. Result: practically nonirritating (0.6 of max 110 overall irritation score)
Two in vitro studies:
OECD 438 (according to guideline and in comliance with GLP): 30 mg test substance were applied on isalated chicken eyes for 10 s with a post treatment incubation 0, 30, 75, 120, 180 and 240 minutes. Negative and positive controls were valid. Result: Irritating to eyes (irritation index 73 of max. 200).
OECD 492 (according to guideline and in comliance with GLP) 50 mg test substance were applied on human-derived epidermal keratinocytes for 6 hours with a post teatment incubation of 18 hours. Negative and positive controls were valid. Result: Irritating to eyes (cell viability was reduced to 6.5 % compared to negativ control).
key information on skin irritation / corrosion:
One in vivo study (no guideline and no information about GLP)
Two in vitro studies:
OECD 439 (according to guideline and in comliance with GLP)
OECD 431 (according to guideline and in comliance with GLP)
All three studies revealed no irritation and/or corrosion potential of the test substance.
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 study available
Additional information
Justification for classification or non-classification
Justification for classification as eye irritating:
The classification is based on two valid in vitro studies (according to guideline and in comliance with GLP), which indicated a eye irritating potential.
The in vivo study followed no guideline and there are no information about the comliance with GLP. The administered dose of 0.1 ml of a 2 % aqueous solution of the test substance corresponds to 2 mg test substance, which is very low compared to the recommended dose of up to 100 mg for OECD 405. The administered doses in the in vitro tests were significant higher and in accordance with the respective guideline.
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.
