Registration Dossier
Registration Dossier
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EC number: 229-129-2 | CAS number: 6416-66-6
Endpoint summary
Administrative data
Description of key information
LD50, oral, rat, 14 days: > 5000 mg/L
LD50, inhalation: not available
LD50, dermal: not available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Similar to OECD 401, a single dose of the substance was administered to rats by gavage
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Number of animals: 10 (5 female and 5 male)- Age at study initiation: 6- 7 weeks- Weight at study initiation: 225 g (male), 190 g (female)- Housing: singly caged- Diet : commercial pelletted diet (added with vit.E) ad libitum- Water : ad libitum for all test durationENVIRONMENTAL CONDITIONS- Temperature (°C): 21°C ± 2°- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- A 25 w/v i solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours
- Doses:
- Dose rate of 20ml/kg (equivalent to 5g/kg. compound)
- Details on study design:
- - Duration of observation period following administration: 14 days- Other observation: clinical symptoms- Autopsy performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death
- Clinical signs:
- other: No clinical symptoms
- Gross pathology:
- No change in organs or tissue
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 5000 mg/kg body weight
- Executive summary:
The determination of oral toxicity of the substance was determined in an, but no guideline is available and the test was not performed on GLP. The test substance was tested in a single dose (5000 mg/kg bw) on rats. The animals were observed for 14 days.
The acute oral median lethal dose LD50 in rats in > 5000 mg/kg body weight.
No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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 study available
Additional information
Acute Oral
The oral toxicity of the substance was determined, but no guideline is available and the test was not performed on GLP. The test substance was tested in a single dose (5000 mg/kg bw) on rats. The animals were observed for 14 days.
The acute oral median lethal dose LD50 in rats in > 5000 mg/kg body weight.
No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.
Acute inhalation
No study available
Acute dermal
No study available
Justification for selection of acute toxicity – oral endpoint
The study has been conducted on the substance itself.
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 bodyweight)
Category 1: LD50 ≤ 5
Category 2: 5 <LD50 ≤ 50
Category 3: 50 < LD50 ≤ 300
Category 4: 300 < LD50 ≤ 2 000
The acute oral median lethal dose LD50 in rats is > 5000 mg/kg body weight.
The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
Inhalation acute toxicity
No data avilable
Dermal acute toxicity
No data available
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