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EC number: 831-109-9 | CAS number: 5837-73-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-09-20 to 2021-11-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Short report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008-05-30
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998-08
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- 2017-10-09
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- methyl 2-hydroxybut-3-enoate
- EC Number:
- 831-109-9
- Cas Number:
- 5837-73-0
- Molecular formula:
- C5H8O3
- IUPAC Name:
- methyl 2-hydroxybut-3-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. Cserkesz u. 90., 1103 Budapest, Hungary
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult rats, min. 8-10 weeks
- Weight at study initiation: 200-300 g
- Fasting period before study: No
- Housing: Max. 3 animals/cage during acclimatisation and individually during exposure in type III polypropylene/polycarbonate cages with certified laboratory bedding
- Diet: Ad libitum (ssniff® SM R/M-Z+H complete diet)
- Water: Ad libitum (tap water)
- Acclimation period: At least 5 days
- Microbiological status: SPF at arrival and kept in a good conventional environment during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): More than 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 14
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10 % area of the total body surface
- % coverage: 10 % area of the total body surface
- Type of wrap: Sterile gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal will then be wrapped with semi-occlusive plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item was removed, using water at body temperature.
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 200, 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- One female animal per dose (200, 1000 and 2000 mg/kg bw) was treated with the test item in the range-finding test and one female animal was treated with a single dose (200 mg/kg bw) in the main test.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighted directly before treatment and at day 7 and 15 or at preliminary sacrifice
- Necropsy of survivors performed: Yes - Statistics:
- Not required
Results and discussion
- Preliminary study:
- A range-finding study was performed to determine the starting dose for the main test. The starting dose of the range-finding study was 200 mg/kg bw. The animal did not die in this first step, therefore one further rat was treated with 1000 mg/kg body weight in range-finding study. This animal did not die in second step, therefore one further rat was treated with 2000 mg/kg body weight in range-finding study. This animal died on Day 1. The animal treated with 1000 mg/kg bw was however humanely killed on Day 5 as the test item caused with some delay corrosive local signs.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks on result:
- not determinable
- Remarks:
- Not determinable as the substance induced delayed local corrosive effects and the study was stopped for animal welfare reasons.
- Mortality:
- Yes, the animal treated with 2000 mg/kg bw died on day 1. Animals treated with 1000 and 200 (main test) mg/kg bw were humanely killed before the end of the 14-day observation period as the test item caused with some delay corrosive local signs.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight was only measured for the rat dosed with 200 mg/kg bw in the range-finding test as all other animals had to be humanely killed before further weighting was possible. The rat dosed with 200 mg/kg bw showed a stable body weight gain.
- Gross pathology:
- Not performed
- Other findings:
- The test item induced local corrosive symptoms like erythema, oedema, crust, (bloody) wounds, scabs and necrosis
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In an acute dermal toxicity study according to OECD guideline 402 and GLP, the test item could not be classified into any toxicity category as delayed local corrosive effects occured.
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402 and GLP, the toxicity of test item was assessed when administered in a single dermal dose to rats at one or more defined dose levels. At first, the range-finding study was performed in one female Han:WIST rat. The starting dose was 200 mg/kg bw. The test item was applied in original form and left in contact with the skin for a 24 hours period in all animals. The animal did not die in this first step, therefore one further rat was treated with 1000 mg/kg body weight in range-finding study. This animal did not die in second step, therefore one further rat was treated with 2000 mg/kg body weight in range-finding study. This animal died on Day 1. The animal treated with 1000 mg/kg bw was however humanely killed on Day 5 as the test item caused with some delay corrosive local signs. Based on this finding one further animal was treated 200 mg/kg bw in main study. This animal was however also humanely killed on Day 4 because of massive skin corrosion developing with time. The study was terminated for animal welfare reasons, because the test item caused massive skin damage up to clear and massive skin corrosion over time at 1000 mg/kg bw, and even at 200 mg/kg bw in the second test animal. This massive skin damage was not to be expected based on the in vitro skin irritation/corrosivity tests classifying the test item as irritant but clearly not as corrosive.
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