Registration Dossier
Registration Dossier
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EC number: 945-517-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Acute Oral toxicity: > 2000 mg/kg body weight
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This is the only test available, performed on a similar substance 01.
However, it follows the OECD 423 Guideline, the EU B.1.tris and it was performed in GLP. Hence, It can be consider a key study.
The Similar substance 02 was tested for acute toxicity on Wistar rats. No signs of toxicity are observed during the experiment at dose 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
The acute oral toxicity test was performed on a similar substance 01 (read-across from supporting substance -structural analogue or surrogate, following the OECD 423 Guideline and EU B.1 tris (Acute Toxicity-Oral, Acute), in GLP.
Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminai sacrifice (day 15). No mortality occurred. No clinical signs of systemic toxicity were noted in any of the animals. Brown and/or black staining of the neck and/or tail by the test substance was noted among the animals during the study period. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of the similar substance 01 in Wistar rats was established to exceed 2000 mg/kg body weight.
The Similar substance 02 was tested for acute toxicity on Wistar rats. No signs of toxicity are observed during the experiment at dose of 2000 mg/kg bw.
Justification for classification or non-classification
Oral acute toxicity
According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, 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 shown in Table 3.1.1:
Oral (mg/kg body weight)
Category 1: LD50 ≤ 5
Category 2: 5 <LD50 ≤ 50
Category 3: 50 < LD50 ≤ 300
Category 4: 300 < LD50 ≤ 2 000
The oral LD50 value of the similar substance in Wistar rats was established to exceed 2000 mg/kg body weight.
The Similar substance 02 was tested for acute toxicity on Wistar rats. No signs of toxicity are observed during the experiment at dose of 2000 mg/kg bw.
The similar substances 01 and 02 are not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008; hence, according to the read-across from supporting substance-structural analogue evaluation, also the registered substance is not classified for this endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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