Registration Dossier

Administrative data

Description of key information

Based on the OECD guideline 404 and 405 studies, zirconium di(acetate) oxide is not considered irritating to skin, but causes irreversible effects to the eyes. 

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:
adverse effect observed (irritating)

Additional information

In a non-GLP OECD guideline 404 study with 3 rabbits (RCC AG, 1986a), application of 0.5 mL of the test substance for 4 hours under occlusive conditions produced no effects at 1, 24, 48 and 72 hours after removal (erythema score: 0, edema score: 0). In the area of application no staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. Based on these results, the substance is considered to be not irritating to skin.

In a non-GLP OECD guideline 405 study with 3 rabbits (RCC AG, 1986b), single instillation of 0.1 mL of the test substance in the conjunctival sac produced irritating effects. The mean 24 + 48 + 72 hours scores were 2.0 for cornea, 0.6 for iris, 1.7 for conjunctival redness and 1.9 for chemosis. After 21 days, the substance still produced corneal opacity (whole area, from slight to severe) and visible vascularization in all 3 animals (mean cornea score of 1.3). Slight redness of conjunctiva (score 1) was still observed after 21 days in one animal. In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed. Based on irreversibility of the effects on the cornea after 21 days post-application, the substance is concluded to produce irreversible effects to the eyes.


Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the mean erythema and edema scores of 0 in the OECD guideline 404 study with rabbits, classification of zirconium di(acetate) oxide for skin irritation is not warranted in accordance with with EU Directive 67/548 and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the irreversible effects on the cornea within the 21 days observation period in the OECD guideline 405 study, zicronium di(acetate) oxide needs to be classified as: Irreversible Effects on the Eye (Category 1), H318 (Causes serious eye damage) according to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. This classification translates into classification according to EU Directive 67/548/EEC as Xi, R41 (risk of serious damage to eyes).