Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference

Based on the results of the read across studies, Oleyl TMAC is considered to be corrosive to skin and eyes.

Endpoint conclusion:
adverse effect observed (corrosive)
Endpoint conclusion:
adverse effect observed (irreversible damage)
Endpoint conclusion:
no study available

Skin

A study was conducted to determine dermal irritation potential of the read across substance, C16-18 and C18-unsatd. TMAC (active: 50%), in rabbits, according to a method similar to OECD Guideline 404. In the study, six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% a.i.) in an occlusive patch fixed with adhesive tape and wrapped with an impervious material, for 4 h. Observations were made at 4 h, 48 h and 10 d post-exposure. If the test substance appeared to be corrosive after 4 h, another study was conducted with a 1 h exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 h, very slight to well-defined erythema, very slight ischemia and very slight oedema were observed, with an average irritation score of 4/8. At 48 h, there was well-defined to moderate erythema, very slight to slight ischemia and very slight or slight oedema and the average irritation score was 5.4/8. After 10 d, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 hour, very slight erythema was observed with an average irritation score of 0.85/8. After 48 h, there was very slight to moderate erythema and very slight or slight oedema and the average irritation score was 1.25/8. No skin effects were observed after 10 d. Under the test conditions, the undiluted test substance (50% a.i.) was concluded to be non-corrosive after 1 h of occlusive exposure, but corrosive after 4 h of occlusive exposure (van Beek, 1982). Based on the results of the read across study, the test substance, Oleyl TMAC is also considered to corrosive to skin.

Overall, based on the results of thein vivoread across study, the test substance, Oleyl TMAC, is considered to be corrosive to skin (as a conservative approach).

Eye

A study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Overall, based on the results of thein vitroread across study, the test substance, Oleyl TMAC, is considered to be corrosive to eyes.

Skin

Based on the effects observed inin vivoskin irritation study with the read across substance, 100% concentrations of Oleyl TMAC is considered to warrant ‘skin corrosive category 1C; H314 - causes severe skin burns and eye damage’ classification according to EU CLP criteria (Regulation EC 1272/2008).

Eye

Based on the effects observed in anin vivoskin irritation study with the read across substance, 100% concentrations of Oleyl TMAC is considered to warrant ‘Eye damage 1; H318- causes serious eye damage’ classification according to the EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion