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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.