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EC number: 229-100-4 | CAS number: 6410-30-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- FINAL REPORT ON THE SAFETY ASSESSMENT OF HC ORANGE NO. 1
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 1 988
- Bibliographic source:
- International Journal of Toxicology, 17(Suppl. 4).-21-37, 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin sanitization study of chemical 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was conducted on 10 female Hartley albino guinea pigs to determine the skin sensitizing effects caused by the application of test chemical.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2-Nitro-4’-hydroxydiphenylamine
- Cas Number:
- 54381-08-7
- Molecular formula:
- C12H10N2O3
- IUPAC Name:
- 2-Nitro-4’-hydroxydiphenylamine
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): HC Orange No. 1
- Molecular formula: C12H10N2O3
- Molecular weight: 405.582 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: >99%
-InChI: 1S/C30H31N/c1-29(2,23-11-7-5-8-12-23)25-15-19-27(20-16-25)31-28-21-17-26(18-22-28)30(3,4)24-13-9-6-10-14-24/h5-22,31H,1-4H3
-Smiles: N(c1ccc(cc1)C(c1ccccc1)(C)C)c1ccc(cc1)C(c1ccccc1)(C)C
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): HC Orange No. 1
- Molecular formula: C12H10N2O3
- Molecular weight: 405.582 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: >99%
-InChI: 1S/C30H31N/c1-29(2,23-11-7-5-8-12-23)25-15-19-27(20-16-25)31-28-21-17-26(18-22-28)30(3,4)24-13-9-6-10-14-24/h5-22,31H,1-4H3
-Smiles: N(c1ccc(cc1)C(c1ccccc1)(C)C)c1ccc(cc1)C(c1ccccc1)(C)C
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley albino
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal : 0.1% test chemical in propylene glycol and Freund's complete adjuvant (FCA)
Dermal: 25% in propylene glycol - Day(s)/duration:
- One week
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 25% in propylene glycol
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 female guinea pigs
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: 1
- Exposure period: one week
- Test groups: 10 guinea pigs
- Control group: no data
- Site: intradermal injection
- Frequency of applications: single application
- Duration: one week
- Concentrations: 0.1% test chemical in propylene glycol and Freund's complete adjuvant (FCA)
A. II.INDUCTION EXPOSURE: Dermal
- No. of exposures: 1
- Exposure period: no data
- Test groups: 10 guinea pigs
- Control group: no data
- Site: area over the injection site
- Frequency of applications: no data
- Duration: no data
- Concentrations: 25% in propylene glycol
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: After a 2-week
- Exposure period: no data
- Test groups: 10 guinea pigs
- Control group: no data
- Site: a previously untreated site.
- Concentrations: 25% in propylene glycol
- Evaluation (hr after challenge): no data
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitizing effects were observed.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No skin sensitizing effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test material 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was considered to be not sensitizing to the skin of 10 female Hartley albino guinea pigs.
- Executive summary:
Skin sanitization study of chemical 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7) was conducted on 10 female Hartley albino guinea pigs to determine the skin sensitizing effects caused by the application of test chemical.
In induction, the guinea pigs were received a single intradermal injection of 0.1%2-Nitro-4’-hydroxydiphenylamine inpropylene glycol and Freund's complete adjuvant (FCA). One week after injection, an occlusive patch containing 25% chemical in propylene glycol was applied to an area over the injection site.The test site was pretreated 24 hours earlier with 10% sodium lauryl sulfate.
After a non treatment period of 2 weeks, animals were challenged to a previously untreated site at concentration of 25%in propylene glycol and later skin reactions were examined.
Since there was no known evidence of contact sensitization, the chemical 2-Nitro-4’-hydroxydiphenylamine (CAS No: 54381-08-7)was considered to be not sensitizing to the skin of10 female Hartley albino guinea pigs.
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