Amines, N-(3-aminopropyl)-N'-C12-18-alkyltrimethylenedi-, reaction products with N-C12-18-alkyltrimethylenediamines and formic acid

Endpoint summary

Description of key information

The dermal irritant potential of the substance was assessed using:
- An in vivo acute dermal irritation/corrosion test performed in rabbit according to OECD 404 guideline and Good Laboratory Practices (Manciaux, 1998 )
The substance was found to be corrosive after 3-minutes of exposure.
The ocular irritant potential of the substance was assessed using:
- The results of the acute dermal irritation / corrosion test performed on rabbit by Manciaux(1998). Additional testing for eye irritation was scientifically not justified because of animal welfare reasons and the substance was considered to be corrosive for 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:

One study was recorded for this endpoint. The study of Manciaux (1998) was reliable without restrictions and was identified as a key study.

In this study, the potential of the substance to induce skin irritation was assessed in rabbit according to the OECD guideline 404 in compliance with the principles of Good Laboratory Practice regulations.

As possible irritant effects were anticipated, the substance was evaluated in one animal in a first assay . 0.5 mL of the undiluted test item were applied in a first assay for a period of 3 minutes to one flank of the rabbit under a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period. The mean values of the scores for erythema and oedema were calculated for the animal.

As the test substance showed corrosive properties in the first assay, the study was considered complete and it was not evaluated on other animals.

A very slight erythema was recorded one hour after removal of the dressing, then a severe erythema, a severe oedema and cutaneous necrosis were noted from day 2 up to day 5. Necrosis was replaced by crusts which have masked cutaneous reactions between day 6 to day 9. A well- defined erythema and dryness of the skin were then noted up to day 15 and a slight oedema was recorded up to day 12. Mean scores over 24, 48 and 72 hours for the animal were 4.0 for erythema and 4.0 for oedema.

The test substance was evaluated as causing severe burns after a 3 minute exposure on rabbit skin.

Eye Irritation / corrosion:

No study was recorded for this endpoint. Based on the results of the in vivo skin irritation/corrosion study performed by Manciaux (1998),

the substance was also considered to be corrosive for rabbit eyes.

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 (Manciaux, 1998) and the criteria laid down in EU directive67/548/EEC, the substance is classified Corrosive with the risk phrase R35.

Translation from classification according to DSD to the classification according to CLP is as follows: C, R35 is translated into Skin Corrosive Category 1A with the hazard statement H314 (Guidance on the application of regulation EC n°1272/2008 , page 240).

Eye Irritation :

Based on the above stated results on skin corrosion (Manciaux, 1998), 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.