Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Acute oral toxicity: LD50  = 1220 mg/kg bw (with 95% CI 1000-1440 mg/kg bw) (Equivalent or similar to OECD 401)


 Acute dermal toxicity: LD50 = >5000 mg/kg bw (Equivalent or similar to OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
not specified
Sex:
not specified
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
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 220 mg/kg bw
Quality of whole database:
There is one acute oral toxicity available and it is similar to OECD TG 401 study with a Klimisch score of 2. And the acute oral toxicity result used for classification and labelling is of sufficient quality and adequate for this dossier.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Just one animal was tested (at the limit dose level)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
5 g/kg bw
No. of animals per sex per dose:
1
Control animals:
no
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
0/1
Clinical signs:
other: No skin irritation
Interpretation of results:
other: not acute toxic
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The acute dermal LD50 for rabbits was determined at >5000 mg/kg bw.
Executive summary:

 In an acute dermal toxicity study (MB 74-604), 1 rabbit was dermally exposed to the test item Ethyl Maltol at a dose of 5000 mg/kg bw.

The LD50 was >5000 mg/kg bw.

There was no mortality or indication of skin irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
There is one acute dermal toxicity available and it is a similar to OECD TG 402 study with a Klimisch score of 2.

Additional information

Acute oral toxicity

There is one acute oral toxicity study in rats available.

In the acute oral toxicity key study (equivalent or similar to OECD 401), 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. Clinical signs observed were lethargy at dose 0.67 g/kg bw, and coma, flaccid muscle tone and heavy breathing at higher doses. The LD50 was 1220 mg/kg bw (with 95% CI 1000-1440 mg/kg bw).

Acute dermal toxicity

There is one acute dermal toxicity study in rabbits available.

In an acute dermal toxicity study (equivalent or similar to OECD 402), 1 rabbit was dermally exposed to the test item Ethyl Maltol at a dose of 5000 mg/kg bw. There was no mortality or indication of skin irritation. The LD50 was >5000 mg/kg bw.

The results from the studies are acceptable to use in the human health assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Ethyl Maltol (CAS No. 4940-11-8) is classified for acute oral toxicity (Category 4) and is not classified for acute dermal toxicity, when the criteria outlined in Annex I of 1272/2008/EC are applied.