Registration Dossier

Administrative data

Description of key information

There are two studies available for skin corrosion/irritation on 2, 2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9.  The first study is a validity one GLP study carried out to OECD404 in 2002, however rather than use of rabbits the study was carried out using weanling domestic pigs.  The second study that is available is a validity 1 study done to GLP following OECD guideline 404.  The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.  There are no studies for eye or respiratory irritation. The lack of data on eye irritationis not a concern as the corrosive classification for the skin will also be applied to the eyes via the hazard statement

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are two studies available for skin corrosion/irritation on 2, 2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9. The first study is a validity one GLP study carried out to OECD404 in 2002, however rather than use of rabbits the study was carried out using weanling domestic pigs. No mortality or clinical signs of toxicity were observed during the 168-hour observation period

Scab formation was observed on all three animals beginning at the 48 hour observation period and extending to the 168 hour observation period (slight crustation). No exfoliation, hair loss, necrosis or scarring were observed. The maximum PII was 3.3 (moderately irritating).

Based on this study 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 can be classified as a mild irritant to the skin (Category 3 according to OECD-GHS.

 

The second study that is available is a validity 1 study but done to GLP following OECD guideline 404. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. A single 3minute, 1 hour and 4 hour, semi-occluded application of the test material to the intact skin of six rabbits produced severe dermal responses. Necrosis, indicative of dermal corrosion was noted in all dose rabbits at the termination of the animals which for those given the 1 hour exposure was 8 days after exposure. The 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 after exposure of 0.5ml of test substance was corrosive to rabbit skin after 3 minute application. There was no necrosis at 1 hour but it was seen at 24 hours. It was therefore classified as corrosive (Category 1B) to the rabbit skin, according to OECD/GHS criteria.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The rabbit study on 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 was used as the basis for classification as it uses the OECD 404 guideline recommended species of the rabbit and therefore the results are comparable with other testing done for classification purposes. The 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 after exposure of 0.5ml of test substance was corrosive to rabbit skin after 3 minute application. There was no necrosis at 1 hour but it was seen at 24 hours.  It was therefore classified as corrosive (Category 1B) to the rabbit skin, according to OECD/GHS criteria. .   There are no studies on eye irritation with 2,2’-(Octadec-9-enylimino)bisethanol CAS 25307-17-9 but due to the corrosive nature to the skin of the substance it is not ethical to carry out this animal study. The corrosive classification of the 2,2’-(Octadec-9-enylimino)bisethanol and the required risk management methods to avoid eye contact, so the lack of an eye irritation study will not affect the safe handling of the substance. 2,2’-(Octadec-9-enylimino)bisethanol will be considered to be corrosive to eyes based on the effects on the skin. There are no studies to assess the potential for 2,2’-(Octadec-9-enylimino)bisethanol to cause respiratory irritation. The corrosive nature of the 2,2’-(Octadec-9-enylimino)bisethanol would be anticipated to result in respiratory irritation but its physical form as a liquid with a low vapour pressure makes inhalation exposure unlikely, and due to the corrosive nature of the substance use resulting in exposure to aerosols is only expected for dilute solutions.