Registration Dossier
Registration Dossier
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EC number: 204-271-8 | CAS number: 118-71-8
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity studies with Ethyl Maltol
- Author:
- Gralla, E.J., Stebbins, R.B., Coleman, L., Delahunt, C.S.,
- Year:
- 1 969
- Bibliographic source:
- Toxicology and applied pharmacology, 15, 604-613
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Limited reported
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-hydroxy-2-methyl-4-pyrone
- EC Number:
- 204-271-8
- EC Name:
- 3-hydroxy-2-methyl-4-pyrone
- Cas Number:
- 118-71-8
- Molecular formula:
- C6H6O3
- IUPAC Name:
- 3-hydroxy-2-methyl-4H-pyran-4-one
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD strain
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- No. of animals per sex per dose:
- 8 rats
- Details on study design:
- Once dosed and 7-day observation period
- Statistics:
- LD50's were calculated with 19/20 confidence limits by the method of Litchfield and Wilcoxon (1949)
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 440 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 274 - <= 1 627
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity of Maltol is 1440 mg/kg bw performed similar to an OECD TG 401 study design.
- Executive summary:
In the acute oral toxicity key study (Gralla et al., 1969; equivalent or similar to OECD 401), male Charles River CD rats (8/group) were administered Maltol by oral gavage (no doses specified) and observed for 7 days.
The LD50 was 1440 mg/kg bw (with 95% CI 1274-1627 mg/kg bw).
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