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Diss Factsheets
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EC number: 270-331-5 | CAS number: 68424-95-3
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28th January 1987 - 20th March 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: the protocol of Guillot-Gonnet-Clément-Brulos published by the AFNOR: FD n° T03-300
- Deviations:
- no
- Principles of method if other than guideline:
- Guinea-pig maximisation test.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea-pig maximisation study was conducted prior to LLNA methodology availability.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Various
- Females nulliparous and non-pregnant:[yes
- Weight at study initiation: 300 to 500 g
- Housing: Polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days before the begining of treatment
- Indication of any skin lesions: none.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 to 70% RH
- Photoperiod (hrs dark / hrs light): a 12-hour light-dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.2% w/v at 0.5 mL
- Day(s)/duration:
- Initial application
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% w/v in 0.5 mL
- Day(s)/duration:
- Every 48 hours following initial application for a total of 7 applications.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.2% w/v at 0.5 mL
- Day(s)/duration:
- 48 hours
- No. of animals per dose:
- 10/sex
1/sex untreated. - Details on study design:
- RANGE FINDING TESTS: A minimum of one treated group of 2 males and 2 females were dosed 0.5 mL (this being the maximum quantity applicable under an occlusive patch) of concentrations of 100% and 0.2% w/v in water . Two concentrations per animal were administered to clipped skin on the dorsal area for 48 hours and kept in contact with the skin under an occlusive patch. The substance was applied once and cutaneous examinations were carried out 6, 24 and 48 hours after removal of the patches.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 7 exposures.
- Exposure period: 48 hours.
- Test groups: 1 test group
- Control group: 1 control group
- Site: clipped upper thoracic region, just behind the right scapulum.
- Frequency of applications: every 48 hour
- Concentrations: 0.5 mL
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Site: untreated region of the abdominal lateral region.
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 6, 24 and 48 hours after removal of the occlusive patch.
- Challenge controls:
- Untreated animal served as controls because the substance was used as supplied (i.e. no vehicle).
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 5% w/v challenge
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- None.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% w/v challenge
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% w/v challenge
- No. with + reactions:
- 0
- Total no. in group:
- 17
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance at 5% w/v not produce any cutaneous sensitising reaction (nil or very weak) in 19 out of 20 animals in the guinea pig maximisation test.
- Executive summary:
In an amended guinea pig maximisation test to evaluate the sensitisation potential of the substance male and female mice (ten animals/sex) were exposed (occlusive) topically to the substance at 0.2% w/v in water during first application followed by 7 topical (occlusive) applications at 5% w/v in water every 48 hours. Following a resting period of 12 days a challenge application was administered topically for 48 hours employing 0.2% w/v in water at 0.5 mL a site away from the site of initial induction. The skin site was monitored for any signs of irritation at 6, 24 and 48 hours post-application. A skin biopsy was taken from those animals in which irritation was observed at 6 hours following the challenge application. Macroscopic and histological evaluations were conducted on these tissues. No other animals exibited signs of irritation for the remainder of the study. Macroscopic and histological evaluations were conducted on these tissues as well. The findings indiacte that the substance is not a skin sensitiser or is a weak sensitiser as reported by the study facilitator.
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