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Toxicological information

Acute Toxicity: oral

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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:
1969
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

Constituent 1
Chemical structure
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

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).