Registration Dossier

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:

There are no data available for the reaction mass. Based on data for the two constituents it can be concluded that the reaction mass is not a skin sensitiser.

Ethanol:

An ear swelling study was used to examine the skin sensitising potential of ethanol. Ethanol was applied twice on the right ear after an induction procedure involving two scapular subcutaneous injection of adjuvant and multiple topical ethanol applications to the abdomen over a period of 14 days. The degree of contact hypersensitivity is deduced from easr swelling measured 24 and 48 hours after application. Ethanol was found not to cause any statistical increase in ear swelling, in contrast to 3 positive controls which all caused a statistically significant increase.

Data is also available from studies using ethanol as a vehicle. In a guinea pig maximisation study that used ethanol as a carrier solvent for the substance being tested (polyakylene glycol block copolymers) no positive reactions were obtained. It can be concluded that ethanol cannot have any significant skin sensitising properties since it was used as a solvent in this study at levels of up to 75%. A study was carried out to evaluate the effect of vehicles (e.g. ethanol) for use in the mouse local lymph node assay (LLNA), and their influence on the skin sensitization potential of fragrance materials. Groups of mice were treated with each test fragrance in ethanol (1:3 or 3:1 mixtures of the two), or with ethanol alone. Although there were no true control data for comparison with the ethanol-alone treated animals, the level of induced T-lymphocyte proliferation was low for ethanol when compared with that for fragrance materials known to be mild to moderate skin sensitizers, and comparable to other inert vehicles tested.

Isopropanol:

The skin sensitisation potential of 2-propanol was assessed in a study performed according to OECD Guidelines for the Testing of Chemicals No. 406 and in compliance with GLP in male and female Hartley guinea pigs (Hill Top Research, Inc, 1980). In the study, 10 animals/sex comprised the 2-propanol test group and 5 animals/sex comprised the control group.  The epicutaneous induction was carried out with 0.4 mL of undiluted 2-propanol (100% w/w) at the upper left quadrant ofthe back of the test group animals (3 induction exposures during 3 weeks, 6 hours with webril paches under occlusion each).  The challenge exposure also was conducted with 0.4 mL of undiluted 2-propanol at the lower left quadrant of the back of the test group and control group animals. Skin reactions were observed and recorded 1 hour after dermal induction and 24 and 48 hours after the challenge exposure. No positive skin reactions were observed in all animals 24 or 48 hours after challenge. Under the experimental conditions and according to the epicutaneous method of Buehler, no cutaneous reactions attributable to the sensitisation potential of 2-propanol were observed in guinea-pigs.  Therefore, the results of this study demonstrated that 2-propanol showed no evidence of contact skin sensitisation in guinea pigs


Migrated from Short description of key information:
Ethanol:
Mouse swelling study: negative
LLNA: negative.

isopropanol:
Skin sensitisation of iso propyl alcohol has been tested on guinea pigs. The test was performed under GLP according to test guidelines (OECD 406, Buehler method) and has demonstrated that the compound is not sensitizing via skin.
Guinea pig maximisation study: negative

Respiratory sensitisation

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

Ethanol:

There are no data for this endpoint.

Isopropanol:

There are no data for this endpoint.

Justification for classification or non-classification

Based on data for the two constituents, the reaction mass does not need to be classified for skin or respiratory sensitisation according to DSD or CLP.

There are no alerts for respiratory sensitisation and both constituents are not skin sensitisers. On this basis and the lack of any specific data on respiratory sensitisation, no classification for respiratory sensitisation is warranted.