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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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) > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Acute oral toxicity

The acute oral toxicity of the substance was evaluated by considering data on the substance itself and data on Similar Substance 01. Justification for Read Across is given in Section 13 of IUCLID.

Target Substance was tested for acute oral toxicity study in five male and five female rats, according to the OECD Guideline 401 (1981). No death occurred after a single administration of 5000 mg/kg which corresponds to the maximum administrable dose level. A slight hypokinesia was observed after treatment but the behaviour and body weight gain of the animals were not influenced by the treatment. The macroscopic investigations revealed no lesion in the animals sacrificed at the end of the observation period.

The oral LD50 value of the substance in rats was established to exceed 5000 mg/kg bw.

The oral acute toxicity of Similar Substance 01 was evaluated with a limit test to albino rat Wistar, according to the OECD Guideline 401 (1987). Two groups, each of 5 males and 5 females, were treated with a 5000 mg/kg bw single dose of the substance suspended in an aqueous solution and administered by oral gavage. Symptoms and mortality after administration were recorded during the observation period of 14 days. Thereafter all animals were submitted to necropsy and macroscopic examination. No mortality occurred during the study period.

The oral LD50 value of the substance in rats was estimated to exceed 5000 mg/kg bw.

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 the oral, dermal or inhalation route according to the numeric criteria.

Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates

(ATE) defining the respective categories are:

-Category 1: ATE ≤ 5 mg/kg bw

-Category 2: 5 < ATE ≤ 50 mg/kg bw

-Category 3: 50 < ATE ≤ 300 mg/kg bw

-Category 4: 300 < ATE ≤ 2000 mg/kg bw


Based on the available experimental data, no classification for acute oral toxicity is warranted under the CLP Regulation (EC 1272/2008).