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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 292-947-3 | CAS number: 91031-45-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One study, investigating the skin sensitising properties of Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) ester (3EO) is available. The study was conducted according to OECD 406 in compliance with GLP (Pittermann, 1994). Female guinea pigs (20 in test group, 10 in control group) were induced with three occlusive epicutaneous exposures at 25% of the test substance in peanut oil. The epicutaneous challenge was conducted 35 days after the first exposure using 20% of the test material. The negative control group was treated with the vehicle only. No positive control data was included in the study report for reliability check. One h after epicutaneous induction, 3 animals of the control group and 4 animals of the treatment group showed weak skin reactions. One day after challenge application, 10% of the treatment group and 20% of the control group showed slight skin reactions. The grade ‘slight skin reactions’ was additionally added by the author and was not evaluated as positive finding for skin sensitisation. After 48 h, 40% of the treatment group and 20% of the control group showed slight skin reactions. Only for one treated animal (5%) weak skin reactions were observed after 48 h and evaluated as positive result. After 72 h, no skin reactions were observed in any animal. No mortality and no significant differences in body weight gain between the treatment and the control group were observed.
In summary, only one animal of the treatment group (5%) showed a positive result for skin sensitisation and thus Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) ester (3EO) was considered as not sensitising.
Conclusion for sensitisation
In conclusion, no evidence of skin sensitisation properties were seen after treatment with Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO).
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
Migrated from Short description of key information:
Skin sensitisation: not sensitising (OECD 406)
Justification for selection of skin sensitisation endpoint:
There is only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
This information is not available.
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) (CAS 91031-45-7) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.
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.
