Registration Dossier
Registration Dossier
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EC number: 216-323-7 | CAS number: 1559-35-9
Endpoint summary
Administrative data
Description of key information
The acute oral LD50 was > 4.6 g/kg
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- This study was conducted in the early days of GLP and prior to guidelines, but was done at a highly reputible laboratory. So extensive details are missing, but there is no reason to question the quality and the results
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- At this time, studies conducted at the Kodak laboratory used an in-house protocol similar to OECD 401
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- No description is available. The standard method was to test the substance as marketed at the time
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None given
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Not provided
- Doses:
- Not provided
- No. of animals per sex per dose:
- Not provided
- Control animals:
- not specified
- Details on study design:
- Not provided
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 674 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: fasted rats
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 8 169 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Fed animals
- Clinical signs:
- other: slight to severe weakness, inactivity, depression, prostration, labored breathing, anorexia, reddish deposit around eyes, nose and mouth and death.
- Gross pathology:
- Not provided
- Interpretation of results:
- Category 5 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 600 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- The study was conducted in the early days of GLP and prior to guidelines. So there is a general lack of detail in the reports, but the work was conducted in a superior facility, so the quality is not in question.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- 24 hour exposure to the depiliated abdomen under an occlusive wrap for 24 hours
- Duration of exposure:
- 24 hours
- Doses:
- 1
- No. of animals per sex per dose:
- not specified
- Control animals:
- no
- Details on study design:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Mortality:
- not specified
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- Category 5 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
Additional information
Justification for classification or non-classification
There acute oral and dermal LD50 values were greater than the limit dose by a large margin. No classification was necessary.
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