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EC number: 945-898-3 | CAS number: 97675-63-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Experimental conditions and detailed results are missing
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- None
- Duration of exposure:
- 24 h
- Doses:
- 5000 and 2500 mg/kg bw
- No. of animals per sex per dose:
- 5/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Examinations performed: Mortality and dermal reactions.
- Necropsy of survivors performed: No - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: indication of slight irritation at 24 h
- Mortality:
- 5000 mg/kg bw: 3 deaths during the first day of observation
2500 mg/kg bw: no death throughout the observation period - Clinical signs:
- other: No clinical signs of toxicity occurred during the study.
- Gross pathology:
- Not applicable
- Other findings:
- - Dermal reactions: 1 erythema was observed at 5000 mg/kg bw at 24 h.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the dermal LD50 of the test substance is 2500 mg/kg bw < LD50 < 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and is classified Category 5 according to the GHS.
- Executive summary:
In an acute dermal toxicity study, 5 rabbits/dose were administered a single dermal dose of the test substance at 5000 and 2500 mg/kg bw. Animals were then observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.
3 deaths occured at 5000 mg/kg bw on the first day of the observation period. No mortality was observed throughout the observation period at 2500 mg/kg bw. No clinical signs of toxicity occurred during the observation period. Dermal reactions noted were limited to one erythema at 24 h at 5000 mg/kg bw.
Under the test conditions, the dermal LD50 of the test substance is 2500 mg/kg bw < LD50 < 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) N° 1272-2008 and is classified Category 5 according to the GHS.
None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Experimental conditions and detailed results are missing
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Essential oil of Canarium commune (Burseraceae) obtained from gum by steam distillation
- EC Number:
- 945-898-3
- Cas Number:
- 97675-63-3
- Molecular formula:
- not relevant for a UVCB substance
- IUPAC Name:
- Essential oil of Canarium commune (Burseraceae) obtained from gum by steam distillation
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- None
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- None
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- None
- Doses:
- 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- No data
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No data
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 370 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other:
- Remarks:
- ±405 mg/kg bw
- Mortality:
- Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively.
- Clinical signs:
- other: Salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death
- Gross pathology:
- No data
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.
- Executive summary:
In an acute oral toxicity study, single oral doses of 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw of the test substance were given to groups of rats (no. not specified). Animals were then observed for mortality and clinical signs of toxicity for 14 days.
Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively. Clinical signs included salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death.
Rat Oral LD50 = 3370±405 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.
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