Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-582-5 | CAS number: 4940-11-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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.
Reference
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
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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.
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.