Registration Dossier

Diss Factsheets

Administrative data

Description of key information

- LD50(oral) > 2000 mg/kg bw. (BASF, 2010)
- LD50(dermal) > 2000 mg/kg bw. (BASF, 2010)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
GLP and guideline compliant study. Database is of high quality.

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
Quality of whole database:
GLP and guideline compliant study. Database is of high quality.

Additional information

acute oral Toxicity

The acute oral toxicity of the test substance was assessed in a GLP compliant study according to OECD guideline 423 and EU method B.1 (BASF, 2010). The test substance was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Hunched posture was observed for all animals on Day 1. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test substance in Wistar rats was found to exceed 2000 mg/kg body weight.

acute dermal Toxicity

The acute dermal toxicity of the test substance was assessed in a GLP compliant study according to OECD guideline 402 and EU method B.3 (BASF, 2010). The test substance was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Chromodacryorrhoea was shown by two animals on Day 1. Other clinical signs were not noted in any of the animals. The application site did not display any signs of skin irritation. The body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.


Justification for selection of acute toxicity – oral endpoint
Reliable guideline study.

Justification for selection of acute toxicity – dermal endpoint
Reliable guideline 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 toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.

 

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 toxicity under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.