Registration Dossier

Administrative data

Description of key information

An acute oral toxicity study conducted according to the OECD TG 401 (1987) and to GLP is available (Huntington Life Science Ltd 964053). 
An acute dermal toxicity study conducted according to the OECD TG 402 (1987) and to GLP is available (Huntingdon Life Sciences Ltd 964054).
For each of the acute oral and dermal route of exposure, the LD50 is > 2000 mg/kg bw.
No inhalation study is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Valid without restriction

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Valid without restriction

Additional information

The acute toxicity of the test substance following single oral administration to male and female rats by gavage was determined in a study which was conducted according to the OECD TG 401 (1987) and was GLP conform (Huntington Life Science Ltd 964053). The animals received a single oral dose of 2000 mg/kg bw of test item. All animals survived. Piloerection was initially seen. Bodyweight gain was mostly unaffected. Necropsy did not reveal any abnormalities. The LD50 was stated to be > 2000 mg/kg bw for both male and female rats.

The acute dermal toxicity following single application was determined in male and female rats in a study which was conducted according to the OECD TG 402 (1987) and was GLP conform (Huntingdon Life Sciences Ltd 964054). The animals received a single oral dose of 2000 mg/kg bw of test item under semi-occlusive conditions. All animals survived and no clinical signs were seen. Bodyweight gain was mostly unaffected. Examination of the skin revealed no irritation or other dermal changes due to treatment. No port mortem findings were noted. The LD50 was stated to be > 2000 mg/kg bw for both male and female rats.

No inhalation study is available. However, in accordance with column 2 of REACH Annex VIII (Specific rules for adaptation from column 1, point 8.5.2) no acute inhalation study has to be provided since exposure of humans via inhalation is not likely, taking into account the granulometric data available for the test substance (Ciba-Geigy Ltd, Report on particle size distribution No. AD-96/1T.PSD, 1996). According to these data, the powder is characterised by a mass median aerodynamic diameter of 25.5 µm, with a percent mass below 4 µm of ca. 10%. Thus, the majority of generated particles cannot penetrate into the broncho-alveolar tract.


Justification for selection of acute toxicity – oral endpoint
key study

Justification for selection of acute toxicity – dermal endpoint
key study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.