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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

For the enpoint of acute toxicity two key studies are available: one for acute oral toxicity and one for acute dermal toxicity. No data are available on acute toxicity via inhalation route. Both studies were performed according to their respective OECD test guidelines and in accordance to GLP.

Acute oral toxicity

The substance is not acute oral toxic. The oral LD50 is > 5000 mg/kg bw.

Acute dermal toxicity

Based on the result of this study, the LD50 value of the test substance was considered to be > 2000 mg/kg in male and female rats under the conditions of this study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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

For this endpoint there is 1 study available. The study was according to OECD TG 401 and GLP. 5 male and 5 female rats were given 5000 mg/kg bw once and were observed for 14 days. 3 animals died during the study. Slightly depressed bodyweight gains were recorded for surviving male rats during the first week of observation, but bodyweight gains of the remaining rats were normal.

Clinical signs included pilo-erection, hunched posture, lethargy, a decreased respiratory rate and ptosis. A comatose-like condition was observed in one male rat prior to death and wet fur was seen in two males. Necropsy of the survivors at termination of the study did not reveal any macroscopic abnormalities.

Based on these observations the LD50 is > 5000 mg/kg bw. The substance is not oral acute toxic and should not be classified.

Acute dermal toxicity

For this endpoint there is 1 study available. The study was according to OECD TG 402 and GLP.

The purpose of this study was to assess the potential toxicity and the approximate LD50 value of the test substance following a single dermal application to Sprague-Dawley rats at a dose of 2000 mg/kg and a control group. Each group consisted of 5 males and 5 females. There were no deaths of animals reported nor test substance-related effects observed in clinical signs, body weight data or necropsy findings.

Based on the results of this study, the LD50 is > 2000 mg/kg bw for the test substance in male and female rats and under the conditions of this study.

Justification for classification or non-classification

Acute oral toxicity

According to the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) the substance is not considered to be classified as acute toxic because the LD50 is > 5000 mg/kg bw.

Acute dermal toxicity

According to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP), the test substance should not be classified as acute toxic as the LD50 is > 2000 mg/kg bw.