Registration Dossier

Administrative data

Description of key information

The substance is of low acute oral and acute dermal toxicity with LD 50s higher than 2000 mg/kg bw, respectively. The tests were performed pursuant to EU Method B.1 (Acute Toxicity (Oral)) 92/69/EEC and OECD Guideline 402 (Acute Dermal Toxicity), respectively. Experimental data on acute inhalation toxicity is not 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

Oral Route of Exposure

In the key study performed according to the protocols of EU Method B.1 (Acute Toxicity (Oral)), groups of Sprague Dawley rats (5 rats/sex/dose) were given a single oral dose (gavage) of the test article at the dose level 2000 mg/kg bw. The animals were observed subsequently for a period of 14 days. No mortality occurred during the14 day observation period. Piloerection which is a common finding in acute toxicity tests was the only clinical sign of systemic toxicity manifested by the test animals. Piloerection was present for up to 4 days following gavage. At necropsy, no gross lesions were observed. As no deaths occurred in the study, the LD 50 of the test article in rats is higher than 2000 mg/kg bw (Huntingdon Life Sciences Limited 1995).

Dermal Route of Exposure

In a limit test performed pursuant to the protocols of the OECD Test Guideline 402, the test article (no data on analytical purity) was applied in a semi-occlusive fashion for 24 hours to the shaved skin of 5 (8 -11 weeks old) Hanlbm: WIST rats/sex at a dose level of 2000 mg/kg bw. Animals were then observed for 14 days. No mortality was registered in the study. Neither clinical signs of systemic toxicity nor local irritation effects at the application site were observed during the 14 day observation period. Necropsy revealed no gross abnormalities. As no deaths occurred in the study, the LD 50 of the test article in rats is higher than 2000 mg/kg bw (RCC Ltd. 1997).

Inhalation Route of Exposure

No data available

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.