Registration Dossier

Administrative data

Description of key information

- Skin irritation: Not irritating (OECD 404, Reliability 1)
- Eye irritation: Not irritating (OECD 405, Reliability 1)

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

Skin irritation:

In an acute skin irritation study, Aluminium ammonium sulfate (0.5 g as a powder) was applied by dermal way to 3 adult males New Zealand white rabbits. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 404 (Acute Dermal Irritation) and EC B.4.

Very slight erythema was observed on the treated site of all the rabbits at 1h after the patch removal. Treated skin sites of all the rabbits appeared normal at 24, 48 and 72 hours. Control skin sites of all the rabbits appeared normal throughout the experimental period. No clinical signs related to treatment, other than dermal irritation, were observed in any of the rabbits during the experimental period. The mean individual scores for erythema and edema were 0.0-0.0-0.0.

Under the test conditions, Aluminium ammonium sulfate is not classified as skin irritant according to the criteria of the Annex VI to the Regulation N°1272/2008 and to the Directive 67/548/EEC.

Eye irritation:

In an eye irritation study, Aluminium ammonium sulfate as powder was applied by instillation (0.1 g) in eyes to 3 adult males New Zealand white rabbits. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 405 (Acute Eye Irritation) and EC B.5.

No abnormalities were detected in the control eye of the rabbits during the course of the study. No damage to corneal epithelium was observed during the examination with fluorescein dye and cobalt blue filter. No clinical signs related to treatment other than eye irritations were observed in any of the three rabbits

No corneal and iridal lesion was observed (mean individual score at 0.0). The mean individual scores for the conjuntivae were 1.0 -1.0 -0.67 for the redness and 0.67 -0.67 -0.33 for the chemosis.

Under the test conditions, Aluminium ammonium sulfate is not classified as irritant to eyes according to the criteria of the Annex VI to the Regulation (EC) N°1272/2008 and the Directive 67/548/EEC.

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available.

Self classification:

Based on the available data, Aluminium ammonium (bis)sulfate is not classified for skin irritation according to the criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.

Based on the available data, Aluminium ammonium (bis)sulfate is not classified for eye irritation according to the criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.