1-Propanol, 2-methyl-3-[(1,7,7-trimethylbicyclo[2.2.1]hept-2-yl)oxy]-

Endpoint summary

Description of key information

Skin sensitisation: Not a skin sensitiser based on testing in OECD TG 406

Skin sensitisation: No skin sensitisation up to 10% (highest dose tested) in a HRIPT.

Respiratory sensitisation (in absence of human data and absence of respiratory sensitisation alerts): not respiratory sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Two studies on skin sensitisation are available a GPMT and a HRIPT test. Both tests revealed a negative result.

OECD TG 406

A GPMT study according to OECD 406 was performed to assess the skin sensitisation potential of Bornafix using the guinea-pig. Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected based on the skin irritation in the preliminary study: Intradermal injection: 5% v/v in Alembicol D and topical application: as supplied. Challenge application: as supplied and 50% v/v in Alembicol D. Ten test and five control guinea-pigs were used in this study. In this study, Bornafix did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals.

HRIPT test

A repeat insult patch test was conducted to determine if the test material would induce dermal sensitization in human subjects. 113 subjects completed the study. A volume of 0.2 ml of test material in alcohol SD 39C (sample A1) was applied to 50% of the subjects and an equal volume of 0.2 ml of test material in alcohol SD 39C:diethylphthalate (75:25) (sample A2) was applied to the other 50% of the subjects. Controls using distilled water instead of the test material were applied in the same manner. During the induction phase the occluded patches using Parke-Davis Readi-Bandages were applied to the back and allowed to remain in direct skin contact for a period of 24 hours. Prior to patch test application, the vehicle was allowed to evaporate for 30-90 minutes. Patches were applied to the same site on Monday, Wednesday and Friday for three consecutive weeks, for a total of 9 applications during the induction period. The sites were graded for dermal irritation and sensitization just prior to re-application. All induction applications for the individual test samples were made to the same site unless the reaction was considered too strong, in which case applications were made to an adjacent area. A rest period of 10-15 days followed the last induction patching. No test materials were applied during that time. At the challenge phase, a challenge patch was applied to a previously untreated test site. An application was made to a pre-exposed area (original site for induction application) concurrently with the challenge at the naive site. Patches were applied as in the induction phase and kept in place for 24 hours after which time they were removed and the challenge site scored. Scoring of the test sites was also done at 48, 72 and 96 hours post-patching. Rechallenge was conducted at naive sites on 8 subjects who reacted to the primary challenge in either sample A1 or A2. The test materials at a lower concentration were occlusively patched at naive sites located on the outer left and right upper arms of the subjects. A second rechallenge was also conducted using the original test material concentration on 7 subjects who reacted at challenge and the first rechallenge. Under the conditions of this study and at completion of all phases of the study, 10% test material in a vehicle of alcohol SD 39C (sample A1) or alcohol SD 39C:DEP (sample A2) did not show evidence of inducing contact sensitization.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Respiratory sensitisation can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2015) that indicate respiratory reactions e. g. from consumer experience or occupational exposure. In case no such data are available the respiratory sensitisation can be assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-4, 2017), which says that if the substance is not a skin sensitiser, it is unlikely to be a respiratory sensitiser.

Justification for classification or non-classification

Based on the available information, the substance does not need to be classified as skin sensitiser according to EU CLP (EC No. 1272/2008 and its amendments).

Based on the available information, the substance does not need to be classified as respiratory sensitiser according to EU CLP (EC No. 1272/2008 and its amendments).