Fatty acids, C16-18 and C18-unsatd., reaction products with diethylenetriamine, di-Me sulfate-quaternized

Endpoint summary

Description of key information

In essence, the substance class is irritating to the skin. Even though no potential for corrosivity was found in an in-vitro Human Skin Model Test according to OECD Guideline 431, a skin irritation potential was determined for partially unsaturated IQAC, DMS quaternised according to the OECD Test Guideline 404 in New Zealand White rabbits.
An eye irritation potential is not expected for the partially unsaturated IQAC, DMS quaternised based on three in-vitro HET-CAM tests and one in-vivo eye irritation study according to OECD Guideline 405. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

In the in vitro Skin Corrosion Human Skin Model Test according to OECD Guideline 431 (adopted 13 April 2004), the topical application of partially unsaturated IQAC, DMS quaternised (no solvent) on the skin tissue for 3 minutes and 1hour exposure was performed to assess the corrosive potential of the test substance. Under the experimental conditions reported, the test item partially unsaturated IQAC, DMS quaternised (no solvent) is non corrosive to skin.

In a primary dermal irritation study performed according to OECD Guideline 404 (Apr. 24, 2002), three young adult New Zealand White rabbits were dermally exposed to 0.5 mL of partially unsaturated IQAC, DMS quaternised (100 % a.i.) moistened with 0.5 mL purified water for 4 hours under semi-occlusive dressing. Animals were then observed for 14 days. The skin reaction was scored according to OECD Guideline 404. One hour after removal of the dressing a well-defined erythema was observed in all animals which progressed into a moderate to severe effect and persisted as very slight up to 10 or 14 days after treatment. A very slight to moderate oedema was recorded in all animals from the 1-hour up to the 72-hour reading or up to 10 days after treatment. Scaling was present in all animals 7 to 14 days after removal of the application patch. No alterations and no corrosive effects were observed on the treated skin.

The partially unsaturated IQAC, DMS quaternised is irritating to the skin based on results of the topical semi-occlusive application in rabbits.

Eye irritation:

In a primary eye irritation study according to OECD Guideline 405 (2002), 0.1 mL of partially unsaturated IQAC, DMS quaternised (75 % in propylene glycol) was instilled into the conjunctival sac of three New Zealand White rabbits. All three animals showed moderate ocular reaction 1 h after application of the test substance (two scores for conjunctivae redness and chemosis). 24 h after application moderate ocular reactions were still observed in all three animals. Cornea opacity or iris irritation was not observed in any of the three animals. Slight irritation of the conjunctivae persisted until 72 h after treatment in all animals but 7 days after application all three animals were without any sign of ocular irritation.

In a primary eye irritation study in albino rabbits with a 5 % dilution of partially unsaturated IQAC, DMS quaternised slight conjunctival effects were observed, which were fully reversible after 24 hours.

In a hen's egg chorioallantoic membrane test (HET-CAM), an validated alternative method to the Draize test, the potential to cause irritation upon first contact with eyes or mucous membranes was assessed by application of the test substance onto the chorioallantoic membrane (CMA). Six eggs were treated with the partially unsaturated IQAC, DMS quaternised (no solvent, 100 % pure). The three assessed endpoints were haemorrhage, coagulation and lysis of the blood vessel. From these data a mean irritancy index is calculated (maximal possible score = 21).

No irritating effects were observed during 5 min incubation with the partially unsaturated IQAC, DMS quaternised (no solvent, 100 % pure). The calculated mean irritancy index is 0.00. Data from two additional HET-CAM tests with solutions of the partially unsaturated IQAC, DMS quaternised, one 75 % in propylene glycol and one 85.7 % in i-propanol/water, show irritancy indices of 1.5 and 0.00, respecitively.

 

In conclusion, the moderate degree of eye irritation observed in-vivo did not necessitate labelling of the partially unsaturated IQAC, DMS quaternised according to the GHS/CLP criteria with respect to eye irritation.

 

 

 

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin irritation: Cat. 2 according to GHS/CLP; R38, Irritating to Skin according to Directive 67/548/EEC

Eye irritation:With a 75 % preparation of partially unsaturated IQAC, palm oil based, contain 25 % propylene-glycol moderate ocular reactions were observed within 24 hour following application of 0.1 mL of the unchanged test substance to the eyes. Effects on the cornea and the iris did not occur. The severity of the observed effects declined with time and the lesions were completely reversible within 7 days. The moderate degree of eye irritation did not necessitate labelling of the test substance according to the GHS/CLP criteria with respect to eye irritation.

No eye irritation could be found in an in-vivo study with a 5% test substance preparation of tallow fatty acid based partially unsaturated IQAC, DMS quaternised (CAS-no. 86088 -85 -9) and in three in-vitro HET-CAM tests with unchanged palm-oil based partially unsaturated IQAC, DMS quaternised (CAS-no. 92201-88-2). On this basis there is no need for classification of partially unsaturated IQACs, DMS quaternised according to EU criteria in Directive 67/548/EEC and GHS/CLP for eye irritation.