Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

The key skin sensitisation study, conducted according to an appropriate OECD test guideline, and in compliance with GLP, reports the test substance, trimethyl(octadecyloxy)silane, to be not sensitising to guinea pig skin (Aventis, 2001).

Key value for chemical safety assessment

Skin sensitisation

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

The key skin sensitisation study, conducted according to an appropriate OECD test guideline, and in compliance with GLP, reports the test substance, trimethyl(octadecyloxy)silane, to be not sensitising to guinea pig skin (Aventis, 2001).

At induction, undiluted test substance was applied twice for 2 weeks epicutaneously onto the skin of the left flanks of 20 test guinea pigs for 6 hours. The test substance was kept in contact with the skin under occlusive dressing. 10 control animals were treated analogously with 0.5 mL of sesame oil.

At challenge, 0.5 mL of undiluted test substance was applied onto the skin of the right flanks of 20 test guinea pigs, kept in contact with the skin for 6 hours under occlusive dressing. 10 control animals were treated in the same way as the test group. Dermal reactions were evaluated at 24 and 48 hours after removal of the test material. Changes in body weight were recorded on the last day of the observation period. At the end of the study period, all the animals were sacrificed and necropsy was performed.

No mortality occurred during the observation period. Expected body weight gain was observed in all the animals. No clinical signs of toxicity were noted in any of the animals. No dermal reactions (erythema or oedema) were noted in any of the test animals at 24 and 48 hours after challenge exposure.

A skin sensitisation study in humans was also available and supported the findings of the key study (Dow Corning Corporation, 1999).

According to ECHA's disseminated dossier, octadecan-1 -ol has been tested for skin sensitisation in a reliable study, conducted according to appropriate OECD test guideline and in compliance with GLP. No sensitisation was observed at 25% or 50% challenge concentrations. The test substance was reported to be not sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for trimethyl(octadecyloxy)silane, no classification is required for skin sensitisation according to Regulation (EC) No 1272/2008.