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:

The results of sensitization by Sodium diacetate were predicted applying read across approaches from the results obtained for: citric, glycolic and lactic acids, sodium glycolate, ammonium lactate and triacetin. According to these read across approaches Sodium diacetate is considered to be not sensitising:

1. Based on the experimental results 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 diacetate is considered to be also not sensitising for the human skin.

2. Based on the experimental results 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 diacetate is considered to be also not sensitising for the human skin.

3. Based on the experimental results 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 diacetate is also considered to be not sensitising.

4. Based on the experimental results 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 diacetate is also considered to be not sensitising.

5. Based on the experimental results 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 diacetate is also considered to be not sensitising.

6. Based on the experimental results 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 diacetate is also considered to be not sensitising.

7. Based on the experimental results 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 diacetate is also considered to be not sensitising.

8. Based on the experimental results 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 diacetate is considered to be also not sensitising.


Migrated from Short description of key information:
Sodium diacetate is considered to be not sensitising.

Justification for classification or non-classification

Sodium diacetate is not sensitizing; non-classified.