Reaction products of amines, dicoco alkyl and glycollic acid

Endpoint summary

Description of key information

The test material was determined to be not irritating to either the skin or eyes of rabbits in vivo under the CLP crteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin

Two studies, one key and one supporting are available for skin irritation:

In the key study performed in accordance with OECD Guideline No. 404 and EC Method B40.5 mL of the test material was applied as supplied to the shaved skin of three albino New Zealand rabbits. An untreated site on the rabbits served as a control. After 4 hours exposure the semiocclusive wrapping was removed and treated sites washed with liquid paraffin. Irritation was recorded using the Draize scale at 1, 24, 48 and 72 hour time points and thereafter at 7 and 14 days.

Application of the test material produced well-defined erythema and very slight oedema. Other skin reactions noted were light brown discolouration of the epidermis and crust formation. All treated skin sites appeared normal at the 14 -day observation.

No evidence of skin irritation was observed on the control patches of the three rabbits.

In a supporting study performed according to EPA OPPTS 870.2500 0.5 mL of a 40% solution of the test material was applied as supplied to the shaved skin of three albino New Zealand rabbits. After 4 hours exposure the semiocclusive wrapping was removed and treated sites washed with distilled water. Irritation was recorded using the Draize scale at 1, 24, 48 and 72 hour time points and thereafter at 7 and 14 days.

Application of the test material produced very slight to well-defined erythema and oedema. All treated skin sites appeared normal at the 14 -day observation.

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Eye

Available information indicated that the test material had the potential to produce severe effects in the rabbit eye. To confirm the initial assessment a Rabbit Enucleated Eye Test (REET) was performed prior to the in vivo study ( see 7.3.2 Supp eye irritation - in vitro Mullaney 2006). The results indicated that the test material was unlikely to cause severe ocular irritancy.

The in vivo study was performed in accordance with OECD Guideline No. 405 and EC Method B5. 0.1 mL of the test material was applied as supplied to the non-irrigated eye of three albino New Zealand rabbits. Irritation and classification was recorded using the Draize and Kay and Calandra scales at 1, 24, 48 and 72 hour time points.

Application of the test material produced minimal to moderate conjunctival irritation. One eye appeared normal at the 24 -hour observation and the remaining two treated eyes appeared normal at the 48 -hour observation.

In the in vitro Rabbit Enucleated Eye Test (REET), five enucleated eyes, obtained from the New Zealand White strain of rabbit, were maintained at a temperature of 32°C ± 1.5"C within the superfusion apparatus. 0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes. The direct effect of the test material on the cornea was assessed by evaluation of corneal thickness, corneal opacity, alteration of corneal epithelium and fluorescein uptake, throughout the duration of the test. The data for all endpoints was assessed and an estimate of ocular irritancy potential made. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).

Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo

Justification for classification or non-classification

Skin:

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.

Eye:

Application of the test material produced minimal to moderate conjunctival irritation. One eye appeared normal at the 24 -hour observation and the remaining two treated eyes appeared normal at the 48 -hour observation. Therefore classification of the substance is not required.