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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
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- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Transport and distribution
- Environmental data
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Specific investigations
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted comparable to EU Guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- No positive control animals were used, different vehicles were used for induction and challenge exposure.
- GLP compliance:
- no
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Redfern Animal Breeders, Brenchley, Kent
- Age at study initiation: young
- Weight at study initiation: 300-400 g - Route:
- other: epicutaneous
- Vehicle:
- other: induction: aqueous ethanol, challenge: acetone
- Concentration / amount:
- concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone - Route:
- other: epicutaneous
- Vehicle:
- other: induction: aqueous ethanol, challenge: acetone
- Concentration / amount:
- concentration used for induction: 0.1 % w/v in aqueous ethanol
concentration used for challenge applications: 0.1 % w/v in acetone - No. of animals per dose:
- 20 (10 male and 10 female)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 14 days
- Test groups: 20 animals
- Control group: 10 animals
- Frequency of applications: weekly intervals
- Duration: 6 hours
- Concentrations: 0.1 % (w/v)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction application (on Day 28)
- Exposure period: one application (6 h duration)
- Concentrations: 0.1 % (w/v)
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- no data
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 % (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A skin sensitization study was conducted on Guinea pigs (Dunkin-Hartley) in a Bühler test. 20 animals were used for testing the substance and 10 further animals were used as control. The test item was applied topically at a concentration of 0.1 % (w/v). For the induction applications, aqueous ethanol and for the challenge applications acetone was used as vehicle. 3 Induction exposures were conducted at weekly intervals and one challenge application was performed. The skin was examined for reactions 24 and 48 hours after patch removal and no reactions were found. Therefore, the test item was considered not to be a skin sensitizer.
Migrated from Short description of key information:
The test substance was found to be not skin sensitising at a non-irritant concentration.
Justification for selection of skin sensitisation endpoint:
only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance was shown to be not skin sensitising at a non-irritant concentration and is therefore not to be classified for skin sensitisation under Regulation (EC) No 1272/2008 (CLP).
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