Registration Dossier

Administrative data

Description of key information

In a GLP-study according to OECD test guideline 423, the LD50 (oral) of the registered substance was determined as > 2000 mg/kg bw.
In a GLP-study according to OECD test guideline 402, the dermal LD50 of the registered substance was determined as > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

For the registered substance, one acute oral study was available. As this study was conducted under GLP-conditions according to an OECD test guideline it was considered as Klimisch 1.

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 423, "Acute Oral Toxicity — Acute Toxic Class Method", December 2001. The study was carried out with two groups consisting of three female animals each given a dose of 2000 mg/kg b.w. respectively. All animals in the study survived the treatment and showed only slight signs of toxicosis. Under the experimental conditions described in this final report, the oral LD50 of the registered substance in rats was found to be above 2000 mg/ kg b.w. (Cognis, 2006).

For the registered substance, one acute dermal study was available. As this study was conducted under GLP-conditions according to an OECD test guideline it was considered as Klimisch 1.

The acute dermal toxicity of the registered substance was investigated in a GLP-study according to OECD test guideline 402. Two groups (control and treatment with 2000 mg/kg bw)) of 5 males and 5 females were used. About 10% of the body surface was clipped 24 hour prior to treatment. The rats were observed for 14 days and subsequently sacrificed and subjected to gross pathology. As no toxicological effects were observed (mortality, body weigt, behaviour and gross pathology), the dermal LD50 of the registered substance was determined as > 2000 mg/kg bw. (Cognis, 2006).

No acute inhalation study was available for the registered substance. As exposure of humans via the inhalative route is unlikely, especially because of the low vapour pressure (0.168 Pa), testing of the inhalative route is - according to REACH Annex VIII (8.5.2) - not appropriate.

Justification for classification or non-classification

Based on the results of the acute toxicity studies, the test item is not subjected to classification and labelling for acute toxic effects according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS/CLP).