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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
Endpoint summary
Administrative data
Description of key information
OECD 406 (guinea pig maximisation test): indication of skin sensitising potential
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- as revised in 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The result of OECD 429 test may be false positive for this substance. So OECD 406 test was performed.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 250 to 300 grams
- Housing: noryl cages measuring 74.3x54.3x25 cm; up to 5 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hours - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- 24h
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- 24h
- No. of animals per dose:
- - control group 10 animals
- test group 20 animals - Details on study design:
- RANGE FINDING TESTS:
2 animals used top test the tolerance by single intradermal injection.
Dose volume: 0.1 mL of test item/each site.
Concentrations tested: 100, 50, 20, 10, 5 and 1% in corn oil.
Draize scoring on day 2 and day 6.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48h
- Test groups: undiluted test item
- Control group: vehicle
- Site: injection site
- Frequency of applications: 1
- Duration: 24h after exposure period
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 24h
- Test groups: 50% in corn oil
- Control group: vehicle
- Site: both flanks
- Concentrations: 50% in corn oil
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- vehicle
- Positive control substance(s):
- no
- Positive control results:
- not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: Category 1B (indication of skin sensitising potential) based on EU GHS criteria
- Conclusions:
- In a GLP-study according to OECD Test Guideline 406, the registered substance was skin sensitising.
- Executive summary:
The potential of the test item, Cardolite NC-513, to induce and elicit delayed dermal sensitisation was assessed in the guinea pig using the maximisation test of Magnusson and Kligman. The results obtained in this study indicate that the test item may elicit a sensitisation response in the guinea pig, being there a 50% incidence of reaction observed at challenge (total of the animals showing reaction at 24 and/or 48 hour examination after challenge), following a period of induction exposure to the test item. These results indicate that the test item, Cardolite NC-513, may act as a sensitizer. The validity of the test system was verified with periodic testing of the positive control.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a Guinea Pig Maximisation Test the registered substance induced (after intradermal induction with 20%) skin reaction in 50% of the treated animals. Therefore, the registered substance is classified as skin sensitiser Category 1B (according to Table 3.4.4 of Commission Regulation (EU) No 286/2011).
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