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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
Endpoint summary
Administrative data
Description of key information
Maximisation test in guinea pigs:
There is no evidence from the test results that the test item is a sensitiser in guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 March 1987 - 3 April 1987
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Principles of method if other than guideline:
- MAGNUSSON-KLIGMAN method
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was carried out in 1987.
- Specific details on test material used for the study:
- The test materal is a clear liquid and was stored in the dark under ambient conditions.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: less than one year old
- Weight at study initiation: 300-350 g
- Housing: aluminium cage with a grid floor beneath which was a peat moss filled tray
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 52%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle - Route:
- intradermal
- Vehicle:
- other: distilled water
- Concentration / amount:
- 10% v/v in distilled water
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% of the test item as supplied
- Day(s)/duration:
- 14 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: topical application
- Vehicle:
- other: distilled water
- Concentration / amount:
- 50% of the test item
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- test group: 20
control group: 10
dose ranging: 2 - Details on study design:
- RANGE FINDING TESTS:
- Injections: 50%, 25%, 10% and 5% v/v in distilled water
- Topical application: 100% as supplied, 50%, 25% and 10% v/v in distilled water
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal induction and topical induction)
- Test groups: 10% v/v of the test item in distilled water (intradermal induction) and 100% of the test item (topical induction)
- Control group: distilled water
- Site: scapular region
- Duration: 7 days
B. CHALLENGE EXPOSURE
- Day(s) of challenge: 3
- Exposure period: 48 h
- Test groups: 50% of the test item in distilled water
- Control group: distilled water
- Site: flank
- Evaluation (hr after challenge): 24h - Challenge controls:
- The control group guinea pigs for each material were similarly treated but with the relevant vehicle replacing the test material.
Twenty four hours after patch removal the treated sites of both test and control groups were assessed for irritation. - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro-chlorobenzene (DNCB)
- Positive control results:
- All of the test group and none of the control group showed positive responses at challenge indicating that DNCB is an extreme sensitiser in guinea piges.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% of the test item in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs , except skin reactions induced by treatment, were noted at anytime during the study .
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs, except skin reactions induced by treatment, were noted at any time duri ng the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% in propylene glycol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs, except skin reactions induced by treatment, were noted at any time duri ng the study.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There is no evidence from the test results that the test item is a sensitiser in guinea pigs.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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