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Diss Factsheets
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EC number: - | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD Guideline for Testing of Chemicals No. 406 "Sikn Sensitisation" (17 July 1992)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Due to the substance's high insolubility in water and the LLNA test method limitations, it is difficult to evaluate whether a LLNA result would be applicable.
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Molecular weight: 455.55
Appearance: light yellow powder
Purity: 98.69%
Storage condition: room temperature (1-30 degree C)
Storage and handling: keep away from ignition sources; avoid contact with eyes and prolonged or repeated skin contact; avoid continuous or repetitive breathing of dust.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Quarantine and acclimation: Animal physical condition and record of health monitoring were checked at the day of animal receipt. Animals were acclimated for 12 days. Only animals with the best appearance were selected for the test after observation during the acclimation period.
Number of used animals: 5 animals for pilot test and 30 animals for main test.
Grouping: animals were weighted one day before the administratin and animals over 300 g were randomly assigned to the test or control groups.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction dose was 1% (w/v), topical induction dose was 20%(w/v) and challenge dose was 5%(w/v)
- Day(s)/duration:
- skin sensitisation was evaluated by observing clinical signs and skin reactions at 24 hours and 48 hours after removal of challenge patch.
- No. of animals per dose:
- Number of animals in treated group: 20 (female)
Number of animals in vehicle control: 10 (female)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction dose 1%, topical induction dose 20%, challenge dose 5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs and mortalities related to the application of the test substance during this study.
- Remarks on result:
- other: see remarks
- Remarks:
- sensitisation rate of 5% at 24 hours after removal of challenge patech.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction dose 1%, topical induction dose 20%, challenge dose 5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs and mortalities related to the application of the test substance during this study.
- Remarks on result:
- other: see remarks
- Remarks:
- sensitisation rate of 5% at 48 hours after removal of challenge patech.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs and mortalities related to the application of the test substance during this study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs and mortalities related to the application of the test substance during this study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no data
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no data
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no data
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no data
Any other information on results incl. tables
Clinical signs and mortality: There was no clinical signs and mortalities related to the application of test substance during this study.
Body weight changes: There was no significant body weight change related to the application of test substance during this study.
Obervation of applied site
(1) Test substance treated group
As a result of observations at 24 hours after removal of challenge patch, score 2 skin reaction (Moderate and confluent erythema) was observed in 1 of 20 animals. In the case of 48 hours after removal of challenge patch, score 3 skin reaction (Intense erythema and swelling) was observed in 1 of 20 animals.
(2) Vehicle control
Skin reaction (edema or erythema) was not observed at 24, 48 hours after removal of challenge patch.
Determination of skin sensitisation
(1) In the case of test substance treated group, sensitisation rates were 5 % at 24, 48 hours after removal of challenge patch, respectively. Therefore, the final sensitisation rate of test substance was 5 % and the test substance was classified as “Weak” (Grade I) sensitizer according to “criteria for skin sensitisation”.
(2) In the case of vehicle control group, sensitisation rates were 0 % at both 24, 48 hours after removal of challenge patch. Therefore, the final sensitisation rate of vehicle was 0 % and vehicle was classified as “Weak” (Grade I) sensitiser according to “criteria for skin sensitisation”.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was evaluated as a non-sensitizing substance.
- Executive summary:
The study was performed to evaluate the skin sensitisation of the test substance in 30 female guinea pigs by guinea pig maximisation test (GPMT) method. Corn-oil was used as the vehicle. Intradermal induction dose was 1% (w/v), topical induction dose was 20% (w/v) and challenge dose was 5%(w/v) for the test substance. Skin sensitisation was evaluated by oberving clinical signs and skin reactions at 24 hours and 48 hours after removal of challenge patch.
(1) There was no clinical signs and mortalities related to the applicaton of test substance during this study.
(2) There was no significant body weight change related to the application of test substance during this study.
(3) In the test substance treated group, sensitisation rate was 5% at 24 and 48 hours after removal of challenge patch. Therefore, the final sensitisation rate of test substance was 5%.
Based on the results decribed above, the sensitisation rate of the test substance was 5% and it was classifed "Weak" (Grade I) sensitizer. Therefore, the test substance was evaluated as a non-sensitizing substance.
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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