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Toxicological information

Endpoint summary

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

SKIN SENSITISATION

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.

RESPIRATORY SENSITISATION

A study was carried out to investigate if exposure to inhaled ethanol can modulate the rat pulmonary inflammatory response resulting from an allergic asthmatic reaction. Brown Norway rats were sensitized and challenged (15 min inhalation, 14 days later) with chicken egg ovalbumin (OVA). Leukocytes were counted in bronchoalveolar lavages (BAL) performed at 6, 24, 36, 48 and 72 h following the challenge and after ethanol exposures (3000 ppm, 6 h/day, daily). Exposure to ethanol did not significantly affect BAL leukocytes after OVA challenge leading to the conclusion that allergic pulmonary inflammation is not up-regulated by inhalation of ethanol (Scarino, 2012).


Migrated from Short description of key information:
Mouse swelling study: negative
LLNA: negative.
Guinea pig maximisation study: negative

Respiratory sensitisation

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

There is no data for this end point.


Migrated from Short description of key information:
no data

Justification for classification or non-classification

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