Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Read-across with the experimental data obtained for Citric acid:

Based on the experimental results (reported under the endpoint record 07.04.01_01 Citric acid) obtained with the analogue Citric acid (Citric acid, 2.5 % aqueous solution, is not sensitizing for the human skin), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing for the human skin.

Read-across with the experimental data obtained for Citric acid:

Based on the experimental results (reported under the endpoint record 07.04.01_02 Citric acid) obtained with the analogue Citric acid (No allergic reactions were seen when 60 patients with hand eczema, all of whom were involved in handling food, were patch tested, covered contact, probably 24 hr, with 2.5% citric acid in petrolatum) , the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing for the human skin.

Read-across with the experimental data obtained for Glycolic acid:

Based on the experimental results (reported under the endpoint record 07.04.01_03 Glycolic acid) obtained with the analogue Glycolic acid (It was not a sensitizer in a modified Draize test in which the intradermal injection challenge was 3% and the topical application challenge was 60%), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing.

Read-across with the experimental data obtained for Sodium glycolate:

Based on the experimental results (reported under the endpoint record 07.04.01_04 Sodium glycolate) obtained with the analogue Sodium glycolate (It was not a sensitizer in a maximization study using guinea pigs, in which induction consisted of intradermal injection of 10% and topical application of 25% Sodium Glycolate; the challenge application was 25%), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing.

Read-across with the experimental data obtained for Ammonium lactate:

Based on the experimental results (reported under the endpoint record 07.04.01_06 Ammonium lactate) obtained with the analogue Ammonium lactate (It was not a sensitizer using guinea pigs, because no erythema was observed after induction or challenge applications), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing.

Read-across with the experimental data obtained for Lactic acid:

Based on the experimental results (reported under the endpoint record 07.04.01_05 Lactic acid) obtained with the analogue Lactic acid (It was not a sensitizer in a maximization study using guinea pigs in which induction consisted of intradermal injection of 0.2% and topical application of 50% Lactic Acid; challenge consisted of intradermal injection of 0.2% and application of 10%), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing.

Read-across with the experimental data obtained for Triacetin:

Based on the experimental results (reported under the endpoint record 07.04.01_07 Triacetin) obtained with the analogue Triacetin (It was not a sensitizer in the "drop-on method" with five guinea pigs), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing.

Read-across with the experimental data obtained for Triacetin:

Based on the experimental results (reported under the endpoint record 07.04.01_08 Triacetin) obtained with the analogue Triacetin (It was not a sensitizer in guinea pigs initially dosed three times over 5 days and challenged after 1, 2, or 3 weeks), the read-across approach was applied and the substance Sodium acetate is considered to be also not sensitizing.


Migrated from Short description of key information:
Sodium acetate is considered to be not sensitizing.

Justification for classification or non-classification