Registration Dossier

Administrative data

Description of key information

Acute toxicity: Oral: LD50 females: > 2000 mg/kg bw (K, Reliability 1)
Acute toxicity: Dermal: LD50 combined: > 2000 mg/kg bw (K, Reliability 1)
Acute toxicity: Inhalation: exposure based waiving

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Oral route:

In an acute toxic class method study, Aluminium ammonium sulfate was administered by gavage to 6 female Wistar rats at a single dose of 2000 mg/kg bw. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

At the dose level of 2000 mg Aluminium ammonium sulfate / kg bw, all animals were found normal after dosing and during the observation period. There was a normal increase in the body weight of all treated animals and no mortality was observed. The gross pathological examination revealed no anormality due to the test substance. Therefore, the acute oral lethal dose (LD50) of Aluminium ammonium sulfate is > 2000 mg / kg bw .

Under the test conditions, Aluminium ammonium sulfate is not classified according to the criteria of the Annex VI to the CLP Regulation and to the 67/548/EC Directive.

Inhalation:

According to the REACH requirements, the acute toxicity by inhalation (required in section 8.5.2) does not need to be conducted since the acute toxicity study is still available by both the oral and the dermal route. However, regarding the aluminium ammonium (bis)sulfate physical state as an inhalable fraction containing powder, human exposure by inhalation should be considered even if the vapour pressure is low.
The granulometry of aluminium ammonium (bis)sulfate showed no detectable particles in the respirable fraction (< 10 µm) and less than 10% of total particles in the inhalable fraction (< 100 µm). These particles are expected to be dissolved by the mucus from the respiratory tract in order to be ingested. Consequently the acute toxicity by inhalation is warranted due to the potential for acute oral toxicity. However, as no systemic effects are observed during the acute oral testing, no systemic toxicity is expected to occur after inhalation of aluminium ammonium (bis)sulfate. Moreover, no local effects are observed during the acute dermal testing, nor in skin and eye irritation studies. Therefore, local toxicity is not expected after aluminium ammonium (bis)sulfate exposure by inhalation.
Finally, no toxicity is expected after exposure of aluminium ammonium (bis)sulfate by inhalation.

Dermal route:

In an acute dermal toxicity study, Aluminium ammonium sulfate was applied by dermal way to 10 males and females Wistar rats at dose levels of 0 (negative control) and 2000 mg/kg bw. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 402 (Acute Dermal Toxicity).

No clinical signs, no significant changes in the body weight and no mortality were observed in the treated group (2000 mg / kg bw) in comparison with the control group. The external and internal examinations revealed no abnormality due to the test substance. The acute dermal lethal dose (LD50) of Aluminium ammonium sulfate in rats is higher than 2000 mg / kg bw.

Under the test conditions, Aluminium ammonium sulfate is not classified according to criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available.

Self classification:

Oral route:

Based on the available data, aluminium ammonium (bis)sulfate is not classified for acute oral toxicity according to the CLP Regulation and according to the criteria of the annex VI to the Directive 67/548/EC as the LD50 is higher than 2000 mg/kg bw.

Inhalation route:

According to the exposure based waiving taking into account both the available granulometry data on the powder and the absence of systemic effects expected during the acute exposure by inhalation (see § 7.2.2), Aluminium ammonium (bis)sulfate is not classified for acute toxicity by inhalation according to the CLP regulation and according to the criteria of the annex VI to the Directive 67/548/EEC.

Dermal route:

Based on the available data, aluminium ammonium (bis)sulfate is not classified for acute dermal toxicity according to the CLP Regulation and according to the criteria of the annex VI to the Directive 67/548/EC as the LD50 is higher than 2000 mg/kg bw.