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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity in rats: LD50 between 300 and 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 000 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 study available

Additional information

Assessment for acute oral toxicity of test substance relied on 2 studies (1967 and 1978), following a weight of evidence approach. No information on the batch composition was available. However, studies on differet batches led to comparable toxicological results.

In the most recent study (1978), a more detailed description of procedure and results was available. Single administration of test substance was done by gavage to 5/rat/sex per group. Concentrations tested were: 316, 1000, 3160 and 5620 mg/kg bw. Rats were observed daily up to 14 days after exposure. Mortality was recorded and an LD50 of ca. 1000 mg/kg was established.

Additional symptoms of poisoning in terms of apathy, reduced dropping, noisy breathing,... were noted.

Main effects in spontaneously dead rats were: discolouration of kidneys, adrenal glands and liver; reduced thymus and spleen size and reduced adipose tissue. No effects were seen at necropsy of sacrificed rats, except for a change in spleen in one rat.

In the other study (1967) many details were lacking. However, main findings were discolouration of urine and faeces, along with discolouration of gastrointestinal tract and hair; mortality was seen, leading to an LD50 value of 1600 mg/kg.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be in the range between 300 and 2000 mg/kg, therefore test substance is classified in Category 4 for acute oral toxicity.