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Diss Factsheets
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EC number: 947-384-4 | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 6 - March 16, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed before adoption of LLNA method.
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mistubishi Kagaku-Foods Corporation
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
FORM AS APPLIED IN THE TEST (if different from that of starting material): Solution
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: Centre de Production Animale
- Weight at study initiation: 317-441 g
- Diet (e.g. ad libitum): Guinea pig diet, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-35
- IN-LIFE DATES: From: February 6, 2006 To: March 16, 2006
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 1.56%
- Day(s)/duration:
- 2 injections
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 3.125% test substance and 50% Freund's Complete Adjuvant in olive oil.
- Day(s)/duration:
- 2 injections
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant in saline solution
- Concentration / amount:
- 50% FCA in saline solution
- Day(s)/duration:
- 2 injections
- Route:
- epicutaneous, open
- Vehicle:
- olive oil
- Concentration / amount:
- 60%, pre-treatment with sodium lauryl sulfate
- Day(s)/duration:
- 1 dose
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 30% and 60%
- Day(s)/duration:
- 24 hrs
- No. of animals per dose:
- 8 females, 3 males in test group
3 females, 2 males in control group - Details on study design:
- RANGE FINDING TESTS: For the pre-maximum non-irritant concentration test, 2 females were injected with 0.78-25% test substance in olive oil. They were then exposed to 7.5-60% test substance in paraffin oil. No necrosis was noted after the intradermal injection. No skin reaction was noted after the topical exposure.
For the maximum non-irritant concentration test, 3 males for induced by intradermal injection with the test substance in olive oil, and then topically with the test substance in paraffin oil. After 16 days, a challenge exposure was done by topical exposure under occlusive dressing at 7.5%-60% test sustance in paraffin oil. No skin reaction was observed. Therefore, 60% was chosen as the maximum dose for the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 and Day 7
- Test groups: 1
- Control group: Yes
- Frequency of applications: One intradermal injection on Day 0, and one topical application on Day 7.
- Concentrations: 1.56% test substance intradermally, 60% test substance topically with pre-treatment with sodium laurate
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 16 days after last induction
- Exposure period: 1 day
- Test groups: 1
- Control group: Yes
- Concentrations: 30 and 60% test substance.
- Evaluation (hr after challenge): 24 and 48 hrs. - Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- Historical controls
Results and discussion
- Positive control results:
- 50-100% of animals were sensitized in the historical positive controls.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Group:
- positive control
- Remarks on result:
- other: No details on results
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance is not sensitising to skin.
- Executive summary:
11 guinea pigs were tested for the skin sensitization of the test substance in the GPMT. 5 animals were used as controls. The test animals were intradermally injected with 1.56% test substance, and a week later topically exposed to 60% test substance. After 16 days, a challenge exposure was done topically with 30 and 60% test substance. No reaction was observed after the challenge exposure. The test substance is not sensitizing to skin.
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.
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