Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(hydroxyethyl) derivs.

Endpoint summary

Description of key information

Corrosive properties are observed following exposures of 3 minutes and longer, with the skin destruction becoming visible after some delay.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Evaluation of dermal irritation/corrosion of Tris (2-hydroxyethyl) tallow diaminopropane, CAS 90367-27-4 (recently redefined as Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated (NLP), CAS 1290049-56-7), also referred to as Tallow-diamine3EO:

 

There is only one study available of high quality, in which Tallow-diamine3EO has been evaluated for acute dermal irritation/corrosion in rabbits according to OECD 404 and in compliance to GLP.

The test substance was applied in a first assay for a period of 3 minutes and 4 hours to one male New Zealand White rabbit. A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24 and 48 hours after removal of the dressing. As the test substance showed corrosive properties in this first assay, the animal was killed for ethical reasons 2 days after application.

Results after a 3-min exposure: No cutaneous reactions were observed at the 1-hour reading. A severe erythema and a severe oedema, together with cutaneous necrosis, were noted on days 2 and 3. After a 4 -hour exposure: A well-defined erythema and a slight oedema were observed at the 1-hour reading. A severe erythema and a severe oedema, together with cutaneous necrosis, were noted on days 2 and 3. Based on the results of this study, Tallow-diamine3EO is considered to be severe corrosive to the skin.

 

Due to corrosive properties in de dermal irritation/corrosion studies with this substance testing in eyes would not be required.

Justification for selection of skin irritation / corrosion endpoint:

Only one study available

Justification for selection of eye irritation endpoint:

Already classified as severely corrosive to the skin. There is one low validity study done on a 5% preparation. However, no data on identity of the substance and no information on observations or gradings is provided. Results are not suitable for evaluation.

Effects on skin irritation/corrosion: highly corrosive

Justification for classification or non-classification

Available data indicate corrosive properties following exposures of 3 minutes and longer. Following exposure of 3 minutes, the skin destruction is observed at examination the next day, but not yet at the observation 1 hour after the exposure. Consequently, GHS classification Corrosive Category 1B is appropriate, with hazard statement H314: Causes severe skin burns and eye damage.

 

Due to corrosive properties demonstrated in the dermal irritation/corrosion study with this substance, testing in eyes is not justified. Under GHS with the hazard phrase ‘H314 Causes severe skin burns and eye damage’ additional classification for eyes is not necessary.

 

There is no information is available following exposure via inhalation. However, with a vapour pressure below 0.0015 Pa at 20°C, the potential for inhalation of vapours is limited. Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected, and classification STOT-SE Cat.3 for respiratory irritation is not required.