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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 September to 2 November 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similarly to OECD Guideline 404 with minor deviations: no certificate of analysis; 4 test sites used: 2 for 4-h exposure, 2 for 24-h exposure; animals not weighed
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no certificate of analysis; 4 test sites used: 2 for 4-h exposure, 2 for 24-h exposure; animals not weighed
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
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 0824AL1
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland, Inc., Denver, USA
- Age at study initiation: Young adults
- Housing: Individually housed in suspended, stainless steel cages
- 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: 29 or 43 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-70 °F
- Humidity (%): 30-70%
- Photoperiod (h dark / h light): 12 h dark / 12 h light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL/site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 4 males and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: 10% of body surface area
- Type of wrap if used: Test material was applied beneath a gauze (1” X 1”), placed directly on the test sites and then covered with porous tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites gently wiped free of excess test material using a paper towel and water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system
ERYTHEMA AND ESCHAR FORMATION:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness): 4
Eschar (scab) formation: 4E
Necrosis: 4N
Superficial necrosis: 4S
OEDEMA FORMATION:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.03
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - Mild and transient irritation; no tissue destruction
- Mean individual scores at 24, 48 and 72 hours after exposure for the 6 animals were 1.5, 1.8, 1.5, 1.7, 1.5, 1.7 for erythema score and 0, 0, 0, 0, 0.2, 0 for oedema score
- See table 1 for further details - Other effects:
- No data
Any other information on results incl. tables
Table 1: Dermal irritation scores*
Animal No. |
Site |
30 min. |
24 h |
48 h |
72 h |
Day 7 |
Erythema |
|
|||||
4951 M |
Front right |
2 |
2 |
1 |
0 |
- |
Front left |
2 |
2 |
2 |
2 |
0 |
|
4952 F |
Front right |
2 |
2 |
2 |
1 |
0 |
Front left |
2 |
2 |
2 |
2 |
0 |
|
4953 M |
Front right |
2 |
2 |
2 |
1 |
0 |
Front left |
2 |
2 |
1 |
1 |
0 |
|
4975 M |
Front right |
2 |
2 |
2 |
1 |
0 |
Front left |
2 |
2 |
2 |
1 |
0 |
|
4989 M |
Front right |
2 |
2 |
2 |
1 |
0 |
Front left |
2 |
2 |
1 |
1 |
0 |
|
4990 F |
Front right |
2 |
2 |
2 |
1 |
0 |
Front left |
2 |
2 |
2 |
1 |
0 |
|
Oedema |
|
|||||
4951 M |
Front right |
0 |
0 |
0 |
0 |
- |
Front left |
- |
- |
- |
- |
0 |
|
4952 F |
Front right |
0 |
0 |
0 |
0 |
0 |
Front left |
1 |
0 |
0 |
0 |
0 |
|
4953 M |
Front right |
0 |
0 |
0 |
0 |
0 |
Front left |
1 |
0 |
0 |
0 |
0 |
|
4975 M |
Front right |
1 |
0 |
0 |
0 |
0 |
Front left |
0 |
0 |
0 |
0 |
0 |
|
4989 M |
Front right |
1 |
0 |
0 |
0 |
0 |
Front left |
1 |
1 |
0 |
0 |
0 |
|
4990 F |
Front right |
1 |
0 |
0 |
0 |
0 |
Front left |
0 |
0 |
0 |
0 |
0 |
* noted at 30 min, 24, 48 and 72 hours and Day 7 after removal of test material;
- = Observation not present
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Alimet is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a primary dermal irritation study performed similarly to OECD guideline 404, six (4 males and 2 females) New-Zealand White rabbits were dermally exposed to 0.5 mL of Alimet, under a semi-occlusive bandage for 4 hours to clipped skin of the back (10% of the body surface area). Animals then were observed for 7 days. Irritation was scored by the method of Draize (1959).
Mild to moderate irritation was observed at the application sites which subsided within 7 days. Mean individual scores at 24, 48 and 72 hours after removal of the test material for the 6 animals were 1.5, 1.8, 1.5, 1.7, 1.5, 1.7 for erythema score and 0, 0, 0, 0, 0.2, 0 for oedema score. In this study, alimet is not a dermal irritant on male/female rabbits.
Under the test conditions, Alimet is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
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.