Registration Dossier
Registration Dossier
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EC number: 700-672-1 | CAS number: 70226-26-5
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:
Skin sensitisation
There are no data available on the skin sensitising potential of Reaction product of lauric acid and oxybis(propanediol) (List No. 700-672-1).
In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 read-across from the structurally related surrogate substance, 2,3-dihydroxyproypl laurate (CAS No. 142-18-7) and the expected metabolite lauric acid (CAS No. 143-07-7) as well as QSAR calculations performed using the OECD Toolbox, were considered for assessment and read-across was conducted based on an analogue and weight of evidence approach.
The skin sensitising potential of the structural surrogate, 2,3-dihydroxyproypl laurate (CAS No. 142-18-7) was tested in a modified Buehler Test similar to OECD guideline 406 (Sterner, 1977). Pirbright-white guinea pigs (10/test group, 5 controls) were induced with an epicutaneous occlusive application of the test substance (25%), on the left dorsum, for 6 h, three times every 7 days. Epicutaneous challenge exposure was conduced 35 days after the first induction with 25% of the test substance on the right flank under occlusive conditions for 6 h. Evaluation of skin reactions was carried out 24 and 48 h after challenge.
All test and control animals showed no skin reactions after 24 and 48 h.
In addition, the skin sensitising potential of lauric acid (CAS No. 143-07-7) was tested in a study similar to OECD guideline 406 (Gloxhuber und Potokar, 1979). Female Pirbright-white guinea pigs (20/test group, 10 controls)were treated with lauric acid (intradermal) during induction exposure (no further details on test material concentration) and with 2.5% of the test substance diluted in ethanol during challenge exposure for 24 h (epicutaneous, occlusive). Skin reactions were evaluated 24 and 48 h post-application.
No skin sensitising effects were observed in the test animals and controls in the study.
In addition, the skin sensitising potential of the main components of Reaction product of lauric acid and oxybis(propanediol) was estimated by means of read across analysis using QSAR calculations. Structural alerts of the test substance using Toxtree (Estimation of Toxic Hazard – A Decision Tree Approach v.2.1.0) were examined. No structural alerts were detected for Dodecanoic acid, monoester with oxybis(propanediol) and Dodecanoic acid, mono- and diester with oxybis(propanediol). Skin sensitisation data could be found using the OECD Toolbox databases from structurally related substances which contain the same organic functional groups, skin sensitisation data could be found in. The results of the substance with the same were organic functional groups were consistently negative (Szymoszek, 2011).
In conclusion, the overall weight of evidence from the available data on skin sensitisation of the structural surrogate and the metabolite and QSAR calculation of the main components of the test substance, do not provide evidence for sensitising properties of Reaction product of lauric acid and oxybis(propanediol) (List No. 700-672-1).
Migrated from Short description of key information:
Based on read-across from surrogate substances the substance Reaction products of lauric acid and oxybis(propanediol) is not sensitising (OECD 406).
Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from structural surrogates and QSAR calculations. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
Based on read-across from surrogate substances following an analogue and weight of evidence approach, the available data on the skin sensitising potential of Reaction product of lauric acid and oxybis(propanediol) (List No. 700-672-1) 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.
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