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Diss Factsheets
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EC number: 700-857-7 | CAS number: -
- 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:
- From 25 June to 20 September 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similarly to OECD Guideline 402 with minor deviations: no certificate of analysis, occlusive conditions were used
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no certificate of analysis, occlusive conditions were used
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-hydroxy-4-(methylthio)butyric acid
- EC Number:
- 209-523-0
- EC Name:
- 2-hydroxy-4-(methylthio)butyric acid
- Cas Number:
- 583-91-5
- Molecular formula:
- C5H10O3S
- IUPAC Name:
- 2-hydroxy-4-(methylthio)butanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Alimet
- Source: Monsanto Company
- Physical state: Amber liquid
- Lot/batch No.: CBA 0506 AL2/NBP 2334433
- Storage condition of test material: Room temperature
- Density: 1.2322 g/mL
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland Laboratory Animals, Denver, USA
- Age at study initiation: Young adults (at least 8 weeks old); females were nulliparous and non-pregnant
- Weight at study initiation: Males: 2.3-3.0 kg; females: 2.4-2.9 kg
- Housing: Individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet (e.g. ad libitum): Lab Rabbit Chow HF (Purina #5326), ad libitum
- Water (e.g. ad libitum): Municipal water supply, ad libitum
- Acclimation period: 24-31 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-70 °F
- Humidity (%): 30-70%
- Photoperiod (h dark / h light): 12 h dark / 12 h light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: 10% of body surface area
- Type of wrap if used: Test material applied directly, covered by gauze and then wrapped with an impervious plastic sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were not washed but wiped free of excess test material
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume with unit): 1.6 or 4.1 mL/kg in 2000 or 5000 mg/kg bw groups, respectively - Duration of exposure:
- 24 hours
- Doses:
- 2000 and 5000 mg/kg
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed twice daily for viability check; pharmacological/toxicological signs were observed at 1, 2 and 4 hours after dosing and daily thereafter for 14 days; weighed at pre-test (at the time of clipping), pre-dose, Day 7 and Day 14
- Necropsy of survivors performed: Yes; surviving animals were killed by intravenous overdose of sodium pentobarbital and examined grossly - Statistics:
- No data
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - At 2000 mg/kg bw: 0/5 male and 0/5 female died
- At 5000 mg/kg bw: 4/5 males and 1/5 female died - Clinical signs:
- other: - Nasal discharge and/or reddening of the eye were observed in one animal in each group on the day of dosing - Severe abnormalities (hypothermia, prostration, decreased food consumption, hypoactivity, hypopnea and ocular discharge) were observed in anima
- Gross pathology:
- - Necropsy of the dead animals revealed abnormalities like postmortem autolytic changes (discolorations) or antemortem stress (testes in body cavity, gastrointestinal irritation)
- Necropsy of the surviving animals revealed reddening of the stomach walls - Other findings:
- - Local irritation reactions at application site: Most animals exhibited severe dermal effects (necrosis followed by eschar formation, fissuring and/or exfoliation of the eschar tissue), generally affecting less than 25% of the dose site, which persisted throughout the study
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal combined LD50 for Alimet is higher than 2000 mg/kg bw in rabbits and therefore it is not classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an acute dermal toxicity study performed similarly to OECD guideline 402, groups of New Zealand White rabbits (5/sex/dose) received a single dermal dose of Alimet at 2000 and 5000 mg/kg bw at dose volume of 1.6 or 4.1 mL/kg, respectively on clipped area of the trunk representing 10% of the total body surface area. The application was occluded and exposure was for 24 hours. Parameters evaluated included survival, clinical observations, body weight gain and necropsy findings in all animals after a 14 days observation period.
Mortality was 0/5 male and 0/5 female at 2000 mg/kg bw and 4/5 males and 1/5 female at 5000 mg/kg bw. All animals exhibited little or no weight change, although one female in 5000 mg/kg bw exhibited loss of weight on Day 7. Clinical signs noted in several animals were nasal discharge and/or reddening of the eye. Severe abnormalities (hypothermia, prostration, food consumption decrease, hypoactivity, hypopnea and ocular discharge) were observed in animals which died on Day 2 or 3. Necropsy of the dead animals revealed abnormalities like postmortem autolytic changes (discolorations) or antemortem stress (testes in body cavity, gastrointestinal irritation). Necropsy of the surviving animals revealed reddening of the stomach walls. The acute dermal combined LD50 was greater than 2000 mg/kg bw.
Adverse dermal reactions noted were severe dermal effects (necrosis followed by eschar formation, fissuring and/or exfoliation of the eschar tissue), generally affecting less than 25% of the dose site, which persisted throughout the study.
Under the test conditions, Alimet is not classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
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