Registration Dossier
Registration Dossier
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EC number: 207-889-6 | CAS number: 499-75-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity
- Author:
- Jenner, Hagan, Taylor, Cook and Fitzhugh
- Year:
- 1 964
- Bibliographic source:
- Food Cosmet. Toxicol. 2(3), 327-343
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Carvacrol
- EC Number:
- 207-889-6
- EC Name:
- Carvacrol
- Cas Number:
- 499-75-2
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-methyl-5-(propan-2-yl)phenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Fasting period before study: 18 hr prior to treatment
- Diet: Food was replaced in cages as soon as animals received their respective doses
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- No data
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks.
- Statistics:
- The LD50's, slope function, and their confidence limits were recorded. LD50'S were computed by the method of Litchfield & Wilcoxon.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 810 mg/kg bw
- 95% CL:
- > 710 - < 920
- Mortality:
- Death within 1 hour to 3 days
- Clinical signs:
- other: Depression within 10 min, coma within 1 hour.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 for acute oral toxicity of Carvacrol in Osborne-Mendel rats is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw.
- Executive summary:
In an acute oral toxicity study similar to OECD 401 (Jenner, 1964), Osborne Mendel rats (5/dose/sex) were given Carvacrol and observed for 14 days.
Deaths occurred between 1 hr and 3 days. Depression was evident within 10 mins and coma within 1 hour.
The LD50 (male/female) is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw.
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