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Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Oral: LD50 > 2000 mg/kg bw (rats)
Dermal: LD50 > 2000 mg/kg bw (rats)
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
Additional information
Acute oral toxicity
The test item was evaluated for acute oral toxicity in Wistar rats as per OECD Guideline No. 423 and Directive 2004/73/EC, B.1tris "Acute Oral Toxicity-Acute Toxic Class Method", April 29,2004.
Two groups, each of three female HanRcc:Wist (SPF) rats, were treated with test item by oral gavage administration at a dosage of 2000 mg/kg bw. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability, and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30minutes, 1, 2, 3 and 5 hours after administration on test day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period. No clinical signs were observed. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
The median lethal dose of test item after single oral administration to female rats observed over a period of 14 days is greater than 2000 mg/kg bw.
Acute dermal toxicity
The acute dermal toxicity of the test item was evaluated in an experimental study according to the OECD Guideline 402 and Directive 92/69/EEC, B.3, "Acute Toxicity-Dermal", July 31, 1992.
Five male and five female HanRcc:WIST (SPF) rats were treated with test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.25g/mL and administered at a volume dosage of 8 mL/kg. The application period was 24 hours.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
No death occurred during the study. All female animals and two male animals showed a slight erythema after removal of the dressing on test day 2. The erythema persisted as slight until test day 4 (two males and two females), 5 (one female) or 6 (two females).
The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
In conclusion, the LD50 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg bw.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity 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. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be greater than 2000 mg/kg, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).
The dermal LD50 value was established to be higher than 2000 mg/kg, which exceeded the highest CLP limit for classification (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).
In conclusion, the test substance is non classified for oral/dermal acute toxicity, according to the CLP Regulation (EC 1272/2008).
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