Registration Dossier

Administrative data

Description of key information

No data are available for the submission substance. A read-across study (LLNA) is available for the read-across substance propoxylated propylidynetrimethanol (TMP PO).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Studies on the skin sensitisation of poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-are not available. Based on existing datasets and structural and chemical considerations, read-across from this substance to a skin sensitisation study on propylidynetrimethanol, propoxylated (TMP PO) is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.

The skin sensitisation potential of TMP PO was assessed in mice using the local lymph node assay (LLNA) according to OECD Test Guideline 429 (ISOPA, 2003). In the study, female CBA/Ca mice (five/group) received 0.5%, 5%, or 50% (v/v) test substance diluted using 4:1 acetone:olive oil (AOO). Lymph node stimulation indices of less than three (3) were measured for the 5% test group relative to AOO vehicle mice. No skin sensitisation effects were observed for TMP PO. 

No evidence of skin sensitisation was seen for TMP PO in mice in a guideline-compliant study using the LLNA. Based on read-across to this study,Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- is not expected to have the potential to induce skin sensitization.

There is no evidence from experience of use thatPoly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-has the potential to cause skin sensitisation in exposed workers.


Migrated from Short description of key information:
Based on existing datasets and structural and chemical considerations, read-across from Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- to a skin sensitisation study on propylidynetrimethanol, propoxylated (TMP PO) is appropriate to meet the REACH Annex VII-IX data requirements. No evidence of skin sensitisation was seen in a local lymph node assay using TMP PO. Based on read-across Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- is not expected to have skin sensitisation potential.

Justification for selection of skin sensitisation endpoint:
Based on existing datasets and structural and chemical considerations, read-across from the substance to a skin sensitisation study on propylidynetrimethanol, propoxylated (TMP PO) is appropriate to meet the REACH Annex VII-IX data requirements. No evidence of skin sensitisation was seen in a local lymph node assay using TMP PO. Based on read-across, the substance is not expected to have skin sensitisation potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no indication from reports in exposed workers that the substance can cause respiratory sensitisation (occupational asthma).

Justification for classification or non-classification

Based on read-across to data on the skin sensitisation potential of propylidynetrimethanol, propoxylated (TMP PO), the substance Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy- is not predicted to be a skin sensitiser.The substance does not meet the criteria for classification as a skin or a respiratory sensitiser according to Regulation 1272/2008/EC.