Registration Dossier

Administrative data

Description of key information

- Oral: LD50 rat > 2000mg/kg (limit test, OECD 401)
- Dermal: LD50 rat > 2000 mg/kg (limit test, OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

In a GLP-compliant acute oral toxicity study following OECD guideline 401, the test substance in 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 was administered by oral gavage to five Tif: RAI f (SPF) rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight for a period of 14 days. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. All animals had recovered from the symptoms within six days. 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. Therefore, the oral LD value in rats was established to exceed 2000 mg/kg body weight (Ciba-Geigy, 1992).

Dermal

In a GLP-compliant acute dermal toxicity study the test article in distilled water was administered to five Tif: RAI f (SPF) rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. No mortality occurred. Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 1 day. The mean 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. In conclusion, the dermal LD50 value in rats was established to exceed 2000 mg/kg body weight (Ciba-Geigy, 1992).


Justification for selection of acute toxicity – oral endpoint
GLP-compliant guideline study

Justification for selection of acute toxicity – dermal endpoint
GLP-compliant guideline study

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 classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

Dangerous Substance Directive (67/548/EEC)

The available study 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 Directive 2009/2/EG.