Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-]

Endpoint summary

Description of key information

No skin or eye irritation are available for the submission substance. Read-across data are available for the read-across substances propoxylated propylidynetrimethanol (TMP PO) and ethoxylated propylidynetrimethanol (TMP EO).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Studies on the skin and eye irritation of Reaction products of 2,2-
dimethylpropane-1,3-diol and methyloxirane are not available. Based on existing datasets, structural and chemical considerations read-across from the substance to 2,2- to skin and eye irritation studies on propylidynetrimethanol, propoxylated (TMP PO) and on propylidynetrimethanol, ethoxylated (TMP EO) 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.

 

In dermal studies in rabbits conducted according to OECD Test Guideline 404, no skin irritation or corrosive effects were observed for TMP PO or for TMP EO respectively (ISOPA, 2002 and Liggett, 1988).

 

In eye irritation studies using TMP PO and TMP EO conducted in rabbits according to OECD Test Guideline 405, slight, reversible irritation of the eyes was observed only (ISOPA, 2002 and Liggett, 1988). These effects do not warrant the classification of these substances as eye irritants.

 

TMP PO and TMP EO are not irritating to the skin or the eyes. Based on read-across to available data on these substances,Reaction products of 2,2-
dimethylpropane-1,3-diol and methyloxirane is not predicted to cause skin or eye irritation.

Justification for selection of skin irritation / corrosion endpoint:
Based on existing datasets and structural and chemical considerations, read-across from the substance to skin irritation studies on propylidynetrimethanol, propoxylated (TMP PO) and on propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to meet the REACH Annex VII-IX data requirements. In the key study conducted in accordance with OECD Test Guideline 404, TMP PO was not irritating to skin. Similarly, the substance is not predicted to cause skin irritation.

Justification for selection of eye irritation endpoint:
Based on existing datasets and structural and chemical considerations, read-across from the substance to eye irritation studies on propylidynetrimethanol, propoxylated (TMP PO) and on propylidynetrimethanol, ethoxylated (TMP EO) is appropriate to meet the REACH Annex VII-IX data requirements. In the key study conducted in accordance with OECD Test Guideline 405, TMP PO was not irritating to eyes. Similarly, the substance is not predicted to cause eye irritation.

Justification for classification or non-classification

Based on read-across to results from skin and eye irritation studies conducted using propylidynetrimethanol, propoxylated (TMP PO) and propylidynetrimethanol, ethoxylated (TMP EO),Reaction products of 2,2-
dimethylpropane-1,3-diol and methyloxirane is not predicted to cause skin or eye irritation. The substance does not meet the criteria for classification for skin or eye irritation according to Regulation 1272/2008/EC.