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EC number: 218-301-2 | CAS number: 2110-78-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-07-14 - 1993-07-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 2-hydroxy-2-methylpropionate
- EC Number:
- 218-301-2
- EC Name:
- Methyl 2-hydroxy-2-methylpropionate
- Cas Number:
- 2110-78-3
- Molecular formula:
- C5H10O3
- IUPAC Name:
- methyl 2-hydroxy-2-methylpropanoate
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: Colorless transparent liquid
- Density: 1.023 g/cm³ (25°C)
- Flash point: 137°C
- impurity: Water (0.1 wt%)
- Molecular weight: 118.12
- Soluble in water and oil
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SD (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc. on July 6, 1993
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks
- Weight at study initiation: 119 +/- 4.1 g (males) and 106 +/- 6.8 g (females)
- Fasting period before study: overnight fast from the evening of the previous day
- Housing: 6 - 10 animals per suspension-type metallic cage for rats
- Diet: ad libitum (pellet food for rats (MF; Oriental Yeast Co., Ltd.)
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2°C
- Humidity (%): 55 +/- 6 %
- Photoperiod (hrs dark / hrs light): 12-hr light/12-hr dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5, 5, 10, 20 and 50 (v/v)%
- Amount of vehicle (if gavage): 1.0 mL/100 g of bw
Preparation of dosing solutions
Designated amounts of the test substance were weighed and dissolved in distilled water to prepare 0.5-50 (v/v)% aqueous dosing solutions. - Doses:
- 50, 500, 1000, 2000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 6 males per dose (50, 500, 1000, 2000 and 5000 mg/kg bw)
6 females per dose (50, 500, 1000, 2000 and 5000 mg/kg bw) - Control animals:
- yes
- Remarks:
- distilled water, 1.0 mL/100 g of body weight
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: Day 0 immediately before administration and Days 2, 7, and 14 using an electronic balance (Model 1219 MP, Carl Zeiss)
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- No preliminary study performed.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 - <= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Four males and 5 females from the 5000 mg/kg group died within 24 hrs after administration.
No other animal from any other group died. - Clinical signs:
- other: Among males, staggering gait occurred in two animals from the 5000 mg/kg group 5 min after administration. These animals showed increased body muscle tone and died 10 min after administration. Other animals started to show sedation and body drooping 3 hrs
- Gross pathology:
- Dead males and females showed congestion and hemorrhage in the lungs and white color changes in the liver and duodenal mucosa. However, surviving males and females showed no particular abnormality at the end of the study.
Any other information on results incl. tables
Table 1: Mortality of rats
Sex | Dose (mg/kg) |
Days after administration | Final death rate |
||||||||||||||
0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | |||
Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 |
50 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
500 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
1000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
2000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
5000 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4/6 | |
Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 |
50 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
500 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
1000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
2000 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/6 | |
5000 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5/6 |
Table 2: General signs and symptoms
Dose (mg/kg) |
Staggering | Body muscle tone |
Sedation | Body dropping |
Collapse | |
Male | 0 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
50 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
500 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
1000 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
2000 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
5000 | 2/6 | 2/6 | 2/4 | 2/4 | 2/4 | |
Female | 0 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
50 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
500 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
1000 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
2000 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | |
5000 | 1/6 | 0/6 | 5/6 | 6/6 | 1/2 |
Number of animals with findings/Number of surviving animals
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The test substance methyl 2-hydroxyisobutyrate was considered weakly toxic in rats. The test item does not meet the classification criteria of Regulation (EC) No. 1272/2008 (CLP Regulation).
- Executive summary:
An oral acute toxicity study of methyl 2-hydroxyisobutyrate was conducted in rats according to OECD Guideline 401.
Briefly, the test substance methyl 2-hydroxyisobutyrate was administered by gavage to male and female SD rats (SPF) to determine its lethal dose and evaluate its acute toxicity.
The LD50 was estimated to be 2,000-5,000 mg/kg in both males and females.
In the monitoring of general signs and symptoms, both males and females from the 5000 mg/kg group showed staggering gait 5-30 min after administration. Two males from this group died 10 min after administration after showing increased body muscle tone. Other males and females gradually showed sedation and body drooping, and some of them died within 24 hrs after showing collapse.
Both males and females from the 50-2000 mg/kg groups showed no changes in general symptoms. Body weight decreased in females from the 5000 mg/kg group 2 days after administration, but normal weight gains were observed thereafter. Males showed no abnormality. Necropsy revealed congestion and hemorrhage in the lungs and white color changes in the liver and duodenal mucosa in dead males and females, but surviving animals showed no particular abnormality at the end of the study.
Based on these findings, methyl 2-hydroxyisobutyrate was considered weakly toxic in rats. The test item does not meet the classification criteria of Regulation (EC) No. 1272/2008 (CLP Regulation).
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