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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reference
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.
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.