Amines, N-tallow alkyltrimethylenedi-, propoxylated

Endpoint summary

Description of key information

The dermal irritant potential of the substance was assessed using:
- Three in vivo acute dermal irritation/corrosion tests performed in rabbit. One study (Lombard, 1986) was disregarded as the report was not signed either by the study director nor by the management of the laboratory and although Good Laboratory Practices compliance was claimed, no certificate was included in the report. The two other studies were performed according to OECD 404 guideline or a similar method in compliance with Good Laboratory Practices (Clouzeau, 1987 and Gobron, 1981b).
Based on the two above mentioned studies, the substance was found to be corrosive after 4 hours of exposure.
The ocular irritant potential of the substance was assessed using:
- An in vivo ocular irritation test performed in rabbit according to a method similar to OECD 405 guideline (Gobron, 1981c).
The substance was found to be corrosive for the eyes.
No data were available to assess the respiratory irritant potential  of the substance.

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

Skin irritation/corrosion:

Three in vivo dermal irritation/corrosion tests performed in rabbit were reported for this endpoint. One study (Lombard, 1986) was disregarded as the report was not signed either by the study director nor by the management of the laboratory and although Good Laboratory Practices compliance was claimed, no certificate was included in the report. The two other studies were performed according to OECD 404 guideline or a similar method in compliance with Good Laboratory Practices (Clouzeau, 1987 and Gobron, 1981b). The Clouzeau study (1987) was identified as the key study and supported by the results of the study performed by Gobron (1981b).

In the study of Clouzeau, the potential of the test substance to induce skin irritation was assessed in 6 rabbits according to the OECD 404 guideline.

A single dose of 0.5 ml of the test substance was applied to the skin of 3 rabbits under a semi-occlusive dressing for a 3-minute exposure period. 3 other rabbits received the test substance under the same protocol but for an exposure period of 4 hours. Skin reactions were observed 1, 24, 48, 72 hours after patch removal and then daily until day 14 in order to observe their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.

After 3 minutes of exposure, the mean scores over 24, 48 and 72 hours for individual animals were 1.7, 3.7 and 3.7 for erythema and 1.7, 4.0 and 2.3 for oedema. Slight to severe erythema and oedema were observed in all animals. These reactions regressed slowly. They were totally reversible in 8 and 13 days in 2 rabbits. Dryness of the skin was still present at the end of the observation period in the remaining one.

After 4 hours of exposure, the mean scores over 24, 48 and 72 hours for individual animals were 3.7 for erythema in one rabbit, the scores of the 2 others were not calculable due to necrosis. Indeed, 24 and 48 hours after application, necrosis were noted in 2 rabbits and persisted until day 6 . Crusts were then observed until day 11 for one animal and till the end of the observation period for the remaining one. For the third rabbit, erythema regressed slowly and was no more visible on Day 14.

Mean scores over 24, 48 and 72 hours for individual animals were 3.0, 4.0 and 4.0 for oedema . Oedema disappeared on Day 7 in all rabbits.

Under these experimental conditions, the test substance was considered to be corrosive to the rabbit skin after 4 hours of exposure.

In the study of Gobron (1981b), 6 male New Zealand White rabbits were treated for 24 h with 0.5 ml of the test substance on intact (right flank) and scarified (left flank) shaved skin. The primary irritation index of the skin was evaluated 24 h and 72 h after the application. The irritation index was calculated to be 7.75. The severe lesions were not revesible. Therefore, the test substance was considered to be highly irritant to rabbit skin.

Eye Irritation / corrosion:

One study was reported for the eye irritation / corrosion endpoint and was selected as a key study. The study of Gobron (1981c) was reliable with restrictions as very few information on the tested substance were reported.

In this study, the potential of the test substance to induce eye irritation was assessed in 6 rabbitsaccording to a method similar to OECD 405 guideline in compliance with Good laboratory practices.

A single dose of 0.1ml of the test item was instilled into one eye, the other eye was not treated and served as control. The eyes were not rinsed after administration of the test item.Ocular reactions were observed 24 and 48 hours after the administration.

24hours after instillation, a grade 4 chemosis was observed in all animals. Such a chemosis (eyes closed because of swollen lids) prevented from examinating iris and cornea. A grade 3 conjunctival redness and a grade 3 discharge were also noted in all animals. Furthermore, withish secretions were noted around lids. 48 hours after instillation, no changes from the previous description were noted.

Since eyes of all rabbits were destroyed on day 3, it was decided to stop the study and kill them for humane reasons.

Under these experimental conditions, the test substance was considered corrosive when administered by ocular route to rabbits.

Respiratory irritation:

No data were available.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin Irritation:

According to the results of the key study (clouzeau, 1987) and the criteria laid down in EU directive67/548/EEC, the substance is classified Corrosive with the risk phrase R34.

Translation from classification according to DSD to the classification according to CLP is as follows: C, R34 after 4 hours of exposure is translated into Skin Corrosive Category 1C with the hazard statement H314 (Guidance on the application of regulation EC n°1272/2008 , page 240).

Eye Irritation:

Based on the results of the key study (Gobron, 1981),the substance must be considered as corrosive for eyes and warrants a classification in category 1 , eye damage according to CLP regulation (Reg 1272/2008/EC)and a classification severely irritating for eyes Xi, R41 according to the directive 67/ 548/ EEC.