Registration Dossier
Registration Dossier
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EC number: 276-684-1 | CAS number: 72480-09-2
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity, LD50: > 2000 mg/kg bw
Acute inhalation toxicity: waiving
Acute dermal toxicity: LD50 male/female: > 2000 mg/Kg bw
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
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is performed on the substance itself, according to the OECD and UE Guideline, in GLP.
Additional information
Acute Oral Toxicity
The acute oral toxicity was determined on the Similar substance 01 according to the OECD Guideline 401 (Acute Oral Toxicity) and EU Method B.1 (Acute Toxicity (Oral), in GLP.
The following death rate was observed: 0 % at 2000 mg/kg
The LOGIT-Model could not be applied to these data. The acute oral toxicity of the substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.
Sedation was observed at 2000 mg/kg and the animals had recovered within 2 observation days. No macroscopical organ changes were observed.
In a supporting study another substance (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 LD50 was set > 1500 mg/kg bw.
Based on the read across principle (read-across from supporting substance -structural analogue or surrogate), the result can be considered for the acute oral toxicity assessment of the substance.
Justification for read across is detailed in the report attached to the IUCLID section 13.
Acute Dermal Toxicity
The acute dermal toxicity was determined on the Similar substance 01, according to the OECD Guideline 402 (Acute Dermal Toxicity) and EU Method B.3 (Acute Toxicity (Dermal), in GLP.
A limit test has been conducted on 5 male and 5 female rats using the single dose of 2000 mg/kg bw.
During the test no death occurred, no variations in the normal increase of the body weight and no macroscopic organ changes have been observed. The LD50 of the test item is greater than 2000 mg/kg bw.
Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered for the acute oral toxicity assessment of the registered substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.
Justification for classification or non-classification
Acute oral 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 values of the similar substance 01 and 02 were > 2000 mg/kg/body weight.
Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), the results can be considered for the acute oral toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.
The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.
Acute dermal 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:
Dermal (mg/kg body weight)
Category 1: LD50 ≤ 50
Category 2: 5 <LD50 ≤ 200
Category 3: 50 < LD50 ≤ 1000
Category 4: 300 < LD50 ≤ 2 000
The oral LD50 value of the Similar substance 01 in Wistar rats was > 2000 mg/kg/body weight.
Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), the result can be considered for the acute dermal toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.
The substance is not classified for dermal toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
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