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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
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
2-ethyl-3-hydroxy-4-pyrone
EC Number:
225-582-5
EC Name:
2-ethyl-3-hydroxy-4-pyrone
Cas Number:
4940-11-8
Molecular formula:
C7H8O3
IUPAC Name:
2-ethyl-3-hydroxy-4H-pyran-4-one
Test material form:
solid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
0.34, 0.67, 1.31, 2.56, 5.0 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1 220 mg/kg bw
Based on:
test mat.
95% CL:
> 1 000 - < 1 440
Mortality:
0.34 g/kg bw (0/10)
0.67 g/kg bw (1/10)
1.31 g/kg bw (5/10)
2.56 g/kg bw (10/10)
5.00 g/kg bw (10/10)
Clinical signs:
other: 0.34 g/kg bw: none 0.67 g/kg bw: lethargy 1.31 g/kg bw: coma, flaccid muscle tone 2.56, 5.0 g/kg bw: coma, flaccid muscle tone, heavy breathing

Applicant's summary and conclusion

Interpretation of results:
other: Acute Toxicity Category 4
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The acute oral LD50 for rats was determined to be 1220 mg/kg bw. Based on this result, the substance is classified as harmful for acute oral toxicity.
Executive summary:

In the acute oral toxicity key study (MB 74-604), 5 groups of rats (10/group) were administered Ethyl Maltol by oral gavage at dose levels of 0.34, 0.67, 1.31, 5.56 and 5.0 g/kg bw.

The LD50 was 1220 mg/kg bw (with 95% CI 1000-1440 mg/kg bw).

Clinical signs observed were lethargy at dose 0.67 g/kg bw, and coma, flaccid muscle tone and heavy breathing at higher doses.