Registration Dossier

Administrative data

Description of key information

The are two studies on Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 to be registered under 2,2’-(C16 -18 (evennumbered, C18 unsaturated) alkyl imino) diethanol CAS 1218787-32-6, available for skin corrosion/irritation a validity 1 GLP study to EOCD 404 except that weanling domestic pigs were used and a validity 2 GLP OECD 404 study in rabbits that show corrosion after a 4 hour exposure OECD/GHS Category 1C.  There is no data on eye irritation but this in 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)

Additional information

There are two studies available for skin corrosion/irritation on Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 to be registered under 2,2’-(C16 -18 (evennumbered, C18 unsaturated) alkyl imino) diethanol CAS 1218787-32-6. 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/moderate scabbing). Exfoliation (slight/moderate) was observed on two of the three animals beginning at the 120 hour observation period extending to the 168 hour observation period.

Based on this study Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 can be classified as a mild irritant to the skin (Category 3 according to OECD-GHS.

 

The second study that is available is a CESIO validity 2 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. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 of the EC. A single 4 -hour, semi-occluded application of the test material to the intact skin of six rabbits produced severe dermal responses. Scar tissue, indicative of dermal corrosion was noted in 5 out of 6 rabbits 14 days after application. The Ethanol, 2,2’-iminobis-, N-tallow alkyl derives was therefore classified as corrosive (Category 1C) 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 CESIO study while validity 2 was used as the basis for classification as it uses the OECD guideline recommended species of the rabbit and therefore the results are comparable with other testing done for classification purposes. After a 4 hour application scar tissue, indicative of dermal corrosion was noted in 5 out of 6 rabbits 14 days after application. The Ethanol, 2,2’-iminobis-, N-tallow alkyl derives was therefore classified as corrosive (Category 1C) to the rabbit skin, according to OECD/GHS criteria.

 

There are no studies on eye irritation with Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 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 Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives 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. Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives will be considered to be corrosive to eyes based on the effects on the skin as the GHS/CLP phases for skin irritation also includes serious eye damage.