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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-020-6 | CAS number: 627-93-0
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:
No studies are available on DMA, however 2 studies are available on the mix of dibasic esters that contains DMA as a component. The Dibasic esters all contain the same functional groups (methyl esters of dicarboxyllic acids) and therefore are considered likely to act in a similar manner in the skin sensitisation assay. Further support for read across is in the category document attached at section 13 of the IUCLID.
The skin sensitization potential of dibasic esters was assessed in two in vivo assays. A mouse Local Lymph Node Assay (LLNA), of reliability 1 according to Klimisch cotation criteria, was selected as a key study based on its high reliability and as it is the reference method endorsed by REACH. Several concentration of dibasic esters blend were tested up to 100%, and no increase in the stimulation indices occurred, illustrating the absence of skin sensitization. This is confirmed by a Guinea-Pig Maximisation Test (GPMT), of reliability 2 according to Klimisch cotation criteria and therefore selected as a supporting study, where the concentrations of 10% and 100% were tested. No cutaneous reactions were observed following challenge, corroborating the absence of skin sensitization potential.
Migrated from Short description of key information:
No studies available on DMA. 2 studies available on the mix of dibasic esters (DBE) that contains DMA as a component
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The respiratory sensitization potential of dibasic esters was not formally assessed in a dedicated study, but there was no indication of specific immunotoxicity in rats exposed by inhalation for up to 90 days (see "7.5. Repeated dose toxicity" section for details).
Therefore dibasic ester blend and Dimethyl adipate specifically, is not considered to be a respiratory sensitizer.
Migrated from Short description of key information:
Not formally assessed but no indication of specific immunotoxicity in 90-day inhalation toxicity studies in rats.
Justification for classification or non-classification
Based on the classification criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP), and given the absence of positive reactions in a LLNA and a GPMT, or signs of specific immunotoxicity in a rat 90 -day toxicity study by inhalation, dimethyl adipate (DMA) is not classified as a skin or respiratory sensitizer.
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.
