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Administrative data

Description of key information

Studies on skin or eye irritation of the test item (di-sodium salt) were not performed. Therefore, information on acute toxicity is derived from experimental data of an analogue substance (calcium salt). Two studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin or eyes (OECD guideline 404 and Fed.Reg 38. No 187). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight to moderate conjuctival irritation. All reaction on skin and eyes has resolved within 8 days or were below treshold of regualtion. Therefore, the substance is considered to be as not-irritating.

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

Read across justification

Studies on skin or eye irritation of the test item (di-sodium salt) were not performed. Therefore, information on acute toxicity is derived from experimental data of an analogue substance (calcium salt). The structure of both salts is similar; the molecule does not include free amino groups, is not surface-active and the pH is between 6 and 7 (a detailed read across justification is given in CSR, Annex I).

Procedure and results

Two studies were performed to evaluate irritating potential of the test material to skin or eyes.

In the first study, four rabbits (2/sex/dose) were each administered a single dermal dose of 0.5 g given as 50% suspension of the test substance (BASF SE 1981). Occlusive application of the test material to intact rabbit skin for four hours did not cause any reaction on animals skin.

In a second study, six rabbits were each administered a single ocular dose of 31 mg of the test substance and observed for eight days after instillation (BASF AG 1981c). A single instillation of the test material into the eye of the rabbit elicited slight, transient chemosis and moderate redness of conjunctiva which was not fully reversible within post observation period.

There are no data available about irritation to the respiratory system.

Discussion

Application of the test substance onto skin did not cause corrosion or irritation. Appllication into the conjunctival sac of the eye caused slight to moderate conjuctival irritation. Conjunctival irritation was not reversible within 8 day post observation period but showed tendency to normalize and the score of irritation was below the treshold of regulation.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EU) 2018/1480.