Registration Dossier

Administrative data

Description of key information

The available data suggests that amides, C12-18 (even-numbered) and C18-unsatd., N-hydroxyethyl is irritating to skin and highly irritating to eyes based on read-across to the structurally similar substances.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A study was conducted to assess the skin irritation potential of structurally similar amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) to rabbits according to OECD guideline 404. The diluted test substance was applied to the shaved skin of three rabbits using an occlusive bandage. After 4 hours, the exposed skin was rinsed then observed for 14 days. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 days. The overall irritation index was 3.67 out of 8. Amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) was considered to be irritating to rabbit skin under the conditions of this study (Mürmann, 1988b).

A study was conducted to assess the skin irritation potential of structural similar amides, C12-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) to rabbit skin according to OECD guideline 404. The shaved skin of 5 rabbits was exposed to the undiluted test substance using occlusive patches for 4 hours. The skin was then observed for effects (scored according to the Draize system) for 21 days after patch removal. Exposure to undilutedtest substancecaused light to moderate erythema and light oedema immediately after removal of the patch. The reactions intensified until the 72 hours observation time point when strong erythema and moderate to strong oedema, as well as eschar formation were seen. No or only traces of the eschar were left in 1/5 and 4/5 animals, respectively, after 21 days. The acute reactions were no longer visible after 14 days. Based on these results, amides, C12-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) wasconsidered irritating to skin (Kästner, 1986).

Eye irritation

A study was conducted to assess the eye irritation potential of structurally similar amides, C18-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) to rabbit eyes according to OECD guideline 405. 0.1 g of ground neat test substance was placed in the lid of the right eye of each rabbit. 72 hours after application, the treated eyes were analysed for cornea damage using a Na-fluorescein solution, then rinsed with warm physiological solution. Effects were evaluated at 1, 24, 48 and 72 hours, as well as at 6, 8, 10, 13, 17 and 21 days after application according to Draize method. Damage still present after 21 days was considered to be irreversible. The mean overall score was 26.8 (maximum possible: 110). Under the conditions of the study, the test substance was considered to be highly irritating to rabbit eye based the irreversible effects noted in cornea and iris of one animal (Mürmann, 1988c).

A study was performed to assess the eye irritation potential of structurally similar amides, C12-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl).Four rabbits received 0.01 mL of undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days, eyes were analysed for reactions based on the Draize appraisal method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 day observation period. Amides, C12-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) wasconsidered highly irritating to eyes (Kästner, 1987).


Justification for selection of skin irritation / corrosion endpoint:
Sufficient data is available on read-across substances.

Justification for selection of eye irritation endpoint:
Sufficient data is available on read-across substances.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin

Based on the available in vivo skin irritation studies, R38 classification according to EC criteria (67/548/EEC) and skin irritation category 2; H315 - causes skin irritation (hazard statement) according to CLP criteria (EC 1272/2008) is warranted.

Eye

The available in vivo eye irritation suggests that Xi; R41, classification is warranted according to EC criteria (67/548/EEC) and classification as irreversible effects on the eye category 1; H318 – causes serious eye damage (hazard statement) is warranted according to CLP criteria (EC 1272/2008).