Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 293-106-3 | CAS number: 91051-53-5
Endpoint summary
Administrative data
Description of key information
- Eye irritation (OECD 405): not irritating (BASF, 2010)
- RA: 112-63-0: skin irritation (OECD 404): irritating (BASF, 1992)
Key value for chemical safety assessment
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Eye irritation:
The eye irritation potential of the test substance was assessed in a GLP compliant study according to OECD guideline 405 and EU method B.5 (BASF, 2010). Single samples of 0.1 mL of the test substance were instilled into one eye of each of three rabbits. The adjacent eye served as a control. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in redness of the conjunctivae. The irritation had completely resolved within 24 hours in all animals.
Skin irritation:
Methyl linoleate (CAS# 112-63-0) was used as a structural analogue read-across substance for skin irritation hazard identification of Fatty acids, safflower-oil, Et esters. It can be expected that methyl linoleate would exert similar reactions on the skin. Upon activity of dermal esterases, methyl linoleate would be cleaved into linoleic acid and methanol, representing sufficient similarity to the metabolites linoleic acid and ethanol, resulting from cleavage of Fatty acids, safflower-oil, Et esters (CAS# 91051 -53 -5).
The undiluted test substance (CAS# 112 -63 -0, methyl linoleate) was tested for acute dermal irritation (OECD 404, GLP) on the dorsal shaved skin of 3 rabbits in a dose of 0.5 ml. The contact time under semi-occlusive conditions was 4 hours.
Slight to moderate erythema and edema were observed during the first 72 hours after exposure. One week after exposure the skin of all three experiemntal animals showed eschar. The irritation effects of one experimental animal reversed within 7 days. The skin of this rabbit still showed eschar. The observed effects of the other two experimental animals reversed completely within 22 days. The test substance proved to be moderately irritating to the skin according to the conditions applied.
Based on these results methyl linoleate needs to be classified and labelled as skin irritant.
Although no signs of skin irritation were observed in the acute dermal toxicity study, the test substance is classified for precautionary reasons as skin irritant.
Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study. Methyl linoleate (CAS# 112-63-0) was used as a structural analogue read-across substance for skin irritation hazard identification of Fatty acids, safflower-oil, Et esters (CAS# 91051-53-5). It can be expected that methyl linoleate would exert similar characteristics in skin irriation. Upon activity of dermal esterases, methyl linoleate would be cleaved into linoleic acid and methanol, representing sufficient similarity to the metabolites linoleic acid and ethanol, resulting from cleavage of the test substance (CAS# 91051-53-3).
Justification for selection of eye irritation endpoint:
Most reliable guideline study.
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for eye irritation but is considered to be classified for skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for eye irritation but is considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.
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.
