Zinc di(acetate)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Weight of evidence: Read-across approach from experimental results on Citric Acid, Glycolic Acid, Sodium Glycolate, Lactic Acid, Ammonium Lactate, Triacetin, and Zinc Stearate.

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 Zinc acetate is considered to be also not sensitizing for the human skin.

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 Zinc 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 Zinc 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 Zinc 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 Zinc 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 Zinc 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 Zinc acetate is considered to be also not sensitizing.

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 Zinc acetate is considered to be also not sensitizing.

Read-across with the experimental data obtained for Zinc Stearate:

Based on the experimental results (reported under the endpoint record 07.04.01_17 Zinc Stearate) obtained with the analogue Zinc Stearate (It was not a sensitizer in 202 subjects tested by means of the Schwartz-Peck Prophetic Patch Test with an eye shadow formulation, containing 10% Zinc Stearate), the read-across approach was applied and the substance Zinc acetate is also considered to be not sensitizing.

Based on the experimental results (reported under the endpoint record 07.04.01_18 Zinc Stearate) obtained with the analogue Zinc Stearate (It was not a sensitizer in 99 subjects tested by means of theDraize-Shelanski Repeated Insult Patch Testwith an eye shadow formulation, containing 10% Zinc Stearate), the read-across approach was applied and the substance Zinc acetate is also considered to be not sensitizing.

Based on the experimental results (reported under the endpoint record 07.04.01_19 Zinc Stearate) obtained with the analogue Zinc Stearate (It was not a sensitizer in 52 female subjects tested with an eye shadow formulation, containing 10% Zinc Stearate twice a day for 28 days), the read-across approach was applied and the substance Zinc acetate is also considered to be not sensitizing.

Migrated from Short description of key information:
Skin sensitisation: Weight of evidence: Zinc acetate is considered to be not sensitizing for skin. Read-across approach from experimental results on Citric Acid, Glycolic Acid, Sodium Glycolate, Lactic Acid, Ammonium Lactate, Triacetin, and Zinc Stearate.

Justification for selection of skin sensitisation endpoint:
Section 7.4.1 information.

Justification for classification or non-classification

based on the available data, the substance is not classified as skin sensitizing.