Registration Dossier

Administrative data

Description of key information

LD50 (rats, M+F): 2120 (1279-4373) mg/kg bw (test material)

LD50 (rats, M+F): 1179 mg/kg bw (AI)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 179 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

The acute toxicity of the target substance via the oral route was evaluated by taking in consideration available data on Similar Substances following the Read Across approach. Justification for Read Across is given in Section 13 of IUCLID.

The key study [Huntsman Textile Effects (Germany) GmbH, 1982], performed according to the OECD Guideline 401, on Similar Substance 01 was predominantly chosen for the assessment of the acute oral toxicity. Five female and five male rats were orally exposed to the substance at 300, 1000, 2500 and 5000 mg/kg bw and the rats were observed for 14 days for mortality, clinical signs, body weight changes. The rats were also subjected to necropsy. The surviving animals recovered within 10 -14 days from the clinical signs while no compound related gross organ changes were observed. Based on the mortality observed an LD50 of 2120 (1279-4373) mg/kg bw for the test material and an LD50 of 1179 mg/kg bw considering the purity of the AI were determined. Based on the LD50 of the AI, the Similar Substance 02 is considered as acute toxic/harmful via the oral route.

Further data retrieved from other similar substances (different salification from target substance) is attached and support the toxicity of the substance to rats. Most of the similar substances present a toxicity when the LD50 is calculated considering the purity of test material. It is notable that there are three studies suggesting a non-toxicity of the substance however the result of the key study is predominantly and conservatively taken into account considering that it is a guideline study whose results are supported by other studies.

Justification for classification or non-classification

The assessment of the classification of the substance is done by taking into consideration available data on similar substances and predominantly data on the key study of Similar Substance 01.

Based on the LD50 retrieved for the test material the substance should not be classified for acute oral toxicity, however, the LD50 calculated for the AI is in the range for classification (300<ATE ≤2000 mg/kg bw). The substance is therefore classified as Acute Tox. 4 (H302) according to the CLP Regulation (EC) No.1272/2008.