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EC number: 459-270-7 | CAS number: 2568-33-4 MBD
- 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:
- 25 February to 1 March 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Qualifier:
- according to guideline
- Guideline:
- other: USFDA Code of Federal Regulations Title 16, Section 1500.41
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methyl-1,3-butandiol
- EC Number:
- 459-270-7
- EC Name:
- 3-methyl-1,3-butandiol
- Cas Number:
- 2568-33-4
- Molecular formula:
- C5 H12 O2
- IUPAC Name:
- 3-methylbutane-1,3-diol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 734242, Source Sponsor
- Expiration date of the lot/batch: Not stated
- Purity test date: Not stated
- Appearance: Clear liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: Not stated
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Applied as supplied
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three male and 3 female New Zealand White rabbits (order weight 2.5 kg-3.0 kg) were used. They were supplied by a Reputable Commercial Supp;ier and arrived at Ithe test site on 17-February 1987. They were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays. They were fed on Special Diet Services Rabbit Diet of satisfactory anaJysis and allowed food and water ad libitum A 12 h light/dark cycle was in operation.
Mean environmental max.imum and minimum temperatures were 17°C and 15°C and mean relative humidity was 60°%.
The animals were allowed an acclimatisation period of 8 days before test commencement.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: two test sites prepared both were shaved and one was also abraded before application.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24h and 72h after patch application
- Number of animals:
- 6
- Details on study design:
- The hair was clipped from the back of each rabbit approximately 24 h before treatment.
The test material (0.5 ml} was applied to each rabbit under two 2.5 cm x 2.5 cm patches of gauze. One site was abraded before application using a sterilin blood lancet.
The patches were covered with Blenderm tape and the entire trunk was bound with Sleek occlusive tape which remained in position for 24 h.
At the end of this period the patches were removed and the skin wiped with damp tissues to remove surplus test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours. 48 h reading not measured.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Remarks on result:
- no indication of irritation
- Remarks:
- effects only monitored for 72 hours
- Irritant / corrosive response data:
- No irritation was noted after a 24 h occluded exposure to MBD.
The primary irritation score for MBD cream was calculated to be 0. - Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- No irritant responses were noted following a 24 h exposure to MBD The primary irritation score was calculated to be O and as such MBD is not classified as a primary skin irritant.
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