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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-551-7 | CAS number: 108-11-2
- 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:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- room temperature was 18.5 to 26 °C rather than 17 to 23 °C
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- room temperature was 18.5 to 26 °C rather than 17 to 23 °C
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylpentan-2-ol
- EC Number:
- 203-551-7
- EC Name:
- 4-methylpentan-2-ol
- Cas Number:
- 108-11-2
- Molecular formula:
- C6H14O
- IUPAC Name:
- 4-methylpentan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Methyl Isobutyl Carbinol, Methyl isobutyl carbinol, 4-methyl-2-pentanol, methyl amyl alcohol.
- Physical state: Clear liquid.
- Analytical purity: 99.7%.
- Lot/batch No.: L-980710.
- Expiration date of the lot/batch: 10 July 1999.
- Stability under test conditions: Not reported.
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England.
- Age at study initiation: Approximately 11 to 13 weeks.
- Weight at study initiation: 2.5 to 3.0 kg
- Housing: Housed individually in stainless steel cages with perforated floors in Building R14 Room 4.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet), ad libitum. In addition, the animals were fed hay on arrival and subsequently three times a week.
- Water (e.g. ad libitum): Drinking water, ad libitum.
- Acclimation period: 12 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 to 26 °C.
- Humidity (%): 41 to 68%
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 / 12
The higher value for temperature recorded was 26 °C. This exceeded the 19 ± 2 °C range stated in the protocol. This deviation was not considered to have affected the integrity or validity of the study. There were no other deviations from the protocol.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL.
- Concentration (if solution): Undiluted, as supplied by the Sponsor. - Duration of treatment / exposure:
- 4 hours, single exposure.
- Observation period:
- 14 days.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-Lumbar region.
- % coverage: Not reported (25 mm x 25 mm).
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for 4 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment site was washed with warm water (34 °C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: After 4 hours.
SCORING SYSTEM: Examination of the treated skin was made on Day 1 (i.e., approximately 60 minutes after removal of the dressing) and on Days 2, 3, and 4 (equivalent to 24, 48, and 72 hours after exposure). Additional daily observations were made to assess reversibility up to a maximum of 14 days.
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation: Grade
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing grading of erythema: 4
Oedema: Grade
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of are well-defined by definite raising: 2
Moderate oedema (edges raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Any other lesion not covered by this scoring system was described.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritant / corrosive response data:
- Refer to Table 1 (Attached) for result of dermal reactions.
Well-defined erythema with slight oedema was seen in all animals. In addition, desquamation of the stratum corneum (characterised by dryness and sloughing) developed in all three rabbits accompanied by thickening of the skin in one rabbit. Dermal responses gradually ameliorated and had resolved in two animals by either Day 10 or 12. However, very slight erythema was still evident in one animal at study termination on Day 14. - Other effects:
- There were not signs of toxicity or ill health in any rabbits during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information not classified according to CLP, classified R38 according to DSD-DPD) Criteria used for interpretation of results: EU
- Executive summary:
A skin irritation study on methyl iso butyl carbinol has been performed in accordance with OECD Guidelines for the Testing of Chemicals No. 404 and in compliance with GLP (Parcell, 1998). In this study, 3 New Zealand White rabbits were exposed to 0.5 mL of undiluted methyl iso butyl carbinol on the clipped dorsal lumbar region under semi-occlusive conditions. Animals were exposed to the test compound for 4 hours and observations were recorded at 1, 24, 48, and 72 hours after removal of the patch and residual test substance. Additional daily observations were made up to a maximum of 14 days. Skin reactions were scored according to a prescribed numerical system. In all 3 animals, well-defined erythema with slight edema was observed. In addition, desquamation of the stratum corneum, characterized by dryness and sloughing of the skin, developed in all animals. In one rabbit, thickening of the skin was observed. Dermal responses were fully resolved by either Day 10 or 12 in 2 animals. However, very slight erythema was still observed in one animal at Day 14. No signs of toxicity or ill health were observed in any rabbit during the observational period. The individual mean scores over 24, 48 and 72 hours were 2.0, 2.0 and 2.0 for erythema and 2.0, 1.0 and 1.7 for edema.
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.