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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD50 (oral) > 2000 mg/kg bw


LD50 (dermal) > 2000 mg/kg bw

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 the key study the test substance was evaluated for acute oral toxicity in Sprague Dawley male/female rats according to OECD Guideline No. 401. The test substance was administered by oral gavage as a single dose of 2000 mg/kg.


The animals were observed for clinical signs of toxicity and mortality. Examination occurred 15 min after intubation, then at 1, 2 and 4h then each day for 14 days.


No clinical signs or mortality was observed. The animal body weight had a normal evaluation. No gross pathological changes were observed on euthanisied animals.


The LD50, by the oral route, in the rat (male+female) > 2000 mg/kg bw.


 


In the supporting study the test substance was evaluated for acute oral toxicity in male/female rats according to EU Method B1.


The substance was administered to groups of 5 animals per sex by oral administration at the dose of 2000 mg/kg. The animals were observed for clinical signs of toxicity and mortality. No mortality was observed.


No clinical signs of toxicity were observed that were considered to be related to treatment in any of the animals. Alopecia and/or scubs were observed on the head of 2 males during the 2nd week of the study period. A macroscopic post mortem examination of the animals at termination did not reveal abnormalities.


The LD50 > 2000 mg/kg bw.


 


Acute dermal toxicity


In the key study the acute dermal toxicity of the test item was evaluated in an experimental study according to OECD Guideline No. 402 and EU Method B.3.


The substance was administered to five rats of each sex by dermal application at 2000 mglkg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the experimental period (day 15).


No mortality occurred. Lethargy and/or hunched posture were observed in two males on days 2 and 3. Yellow discolouration o f the treated skin area was seen in all animals on day 2.


Body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found in the animals at macroscopic post mortem examination.


The dermal LD50 value of the test item in rats was established > 2000 mg/kg body weight.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), classification for acute toxicity by oral and dermal route is required below the threshold value of 2000 mg/kg bw.


Based on available data the test substance is not classified for acute oral or dermal toxicity.