Registration Dossier
Registration Dossier
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EC number: 478-130-6 | CAS number: 50940-49-3
Endpoint summary
Administrative data
Description of key information
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was approximately 775 mg/kg bodyweight with no mortality at 300 mg/kg bodyweight (LC0) and 100% mortality at 2000 mg/kg bodyweight (LC100).
Acute toxicity inhalation study is considered inappropriate as there is likely to be no human exposure to aerosols, particles or droplets of an inhalable size.
Acute dermal toxicity was deemed inappropriate as the test material has already been classified as as corrosive to rabbit skin.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 775 mg/kg bw
- Quality of whole database:
- LD50 is estimated as geometric mean between LC0 of 300 mg/kg bw and LC100 of 2000 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
Acute Oral Toxicity. A study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 17 December 2001).
- Method B1 tris Acute Toxicity (Oral) of Commission Directive 2004/73/EC
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was approximately 775 mg/kg bodyweight.
A repeated dose rangefinder showed no mortality exposing rats to 750 mg/kg bw/day for 14 days.
Acute Toxicity Inhalation: In accordance with Column 2 Adaptation, Annex VII (8.5.2) of REACH REgulation 1272/2008, testing by inhalation route is inappropriate since the substance is considered not sufficiently volatile. Therefore, there is likely to be no human exposure to aerosols, particles or droplets of an inhalable size.
Acute Toxicity Dermal: In accordance with REACH Regulation, Annex VIII (8.1.1) of REACH Regulation 1272/2008, the study does not need to be conducted if the substance is classified as as corrosive to the skin or as a skin irritant. The test material has already been classified as as corrosive to rabbit skin.
Justification for classification or non-classification
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was above 300 mg/kg bodyweight (LC0) but below 2000 mg/kg bodyweight (LC100). According to CLP, classification is acute oral Category 4.
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