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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD50 = 11205 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:
11 205 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

There are no experimental available data of the target substance, thus the information on the Similar Substance 02 has been taken into account. The structural differences occurring between the target substance and Similar Substance 02 are not expected to significantly impact the acute toxicity, thus the read across approach can be considered as representavive and appropriate (details in the document attached to the IUCLID section 13).

The test substance was tested for acute oral toxicity in rats Wistar strain according to OECD 401.

Logaritmic doses between 1585 and 6310mg/kg were somministered and mortality was observed at the 14th day.

Clinical signs were observed and macroscopic autopsy was performed after the last administration of 1585 mg/kg bw.

Urine biochemical test was also performed.

Characteristics of the sample toxicity was calculated according to the assess evaluation of clinical symptoms of intoxication patomorfologic changes to mortality in the course of a 14-day experiment.

In a supporting study the acute oral toxicity in the rat was performed in compliance with method B1 of Directive 92/69/EEC and OECD 401 (Sumitomo Chemical, 1998).

The full study was performed given the test article as a single dose by oral gavage at the limit dose level of 2000 mg/kg bw. All animals were killed on day 15 and subsequenly underwent a full necropsy. No animal died.

Clinical signs of reaction to treatment included a red staining to the fur or a pink tinge to the fur, tail and feet. All rats achieved body weight gains during the first and second weeks of the study. No macroscopic changes were apparent during necropsy of rats killed on day 15. The acute median lethal dose of the tested substance LD50 was found to be > 2000 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

According to the CLP criteria n.1272/2008, the substance is not classified as toxic for the oral exposure as its LD50 is > 2000 mg/kg bw.