Registration Dossier
Registration Dossier
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EC number: 275-203-2 | CAS number: 71119-23-8
Endpoint summary
Administrative data
Description of key information
In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the source substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form of the source substance (CAS 4432-31-9) and also for the target substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to section 13 for the read-across justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD TG 423, GLP
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
No study data with the test item is available for acute oral toxicity. Therefore, a read-across to the read-across source substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the acute oral toxicity potential of the test item.
The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423. The study was conducted in two consecutive steps with three rats per step. All six female rats treated with 2000 mg/kg bw by oral gavage survived the observation period. No signs of toxicity were detected. The body weight development was normal. Gross pathology showed no test substance related alterations. The LD50 value of the test substance is considered to be >2000 mg/kg bw. The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form of the source substance (CAS 4432-31-9) and also for the target substance.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for acute oral toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.
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