Registration Dossier

Toxicological information

Endpoint summary

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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:

In a Local Lymph Node Assay (LLNA), Aluminium ammonium (bis) sulfate was tested for skin sensitisation on female CBA mice, according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) and in compliance with the principles of Good Laboratory Practices.

Following a preliminary screening test using a 50% w/v suspension considered as suitable, the Aluminium ammonium (bis) sulfate was administered topically at 10, 25 and 50% in propylene glycol once daily on 3 consecutive days (days 1, 2 and 3). The vehicle alone was used as a negative control. Positive controls for the LLNA test are performed every six months in the laboratory.

There were no clinical signs indicative of a systemic effect of treatment among mice treated with the vehicle or with 10, 25 or 50% w/v formulations of Aluminium ammonium (bis) sulfate. The vehicle and the test formulation application sites remained free of irritation. There was no indication of a treatment related effect on body weight.

The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0, and all test substance concentrations tested are under this threshold.

The Local Lymph Node Assay demonstrated that Aluminium ammonium (bis) sulfate does not have the potential to cause skin sensitisation.

Aluminium ammonium (bis) sulfate did not meet the criteria for classification as a sensitiser according to the criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.



Migrated from Short description of key information:
- Skin sensitisation: Not sensitising (OECD 429, Reliability 1)

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available.

Self classification:

Aluminium ammonium (bis) sulfate is not classified for skin sensitisation according to the criteria of the Annex VI to the CLP regulation and according to the criteria of the Annex VI to the Directive 67/548/EEC.