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Diss Factsheets
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EC number: 268-048-7 | CAS number: 67990-27-6
- 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
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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:
- Experimental study on skin sensitization potencies and cross-reactivities of hair-dye-related chemicals in guinea pigs
- Author:
- Zhenlin Xie et.al
- Year:
- 2 000
- Bibliographic source:
- Contact Dermatitis
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson & Kligman guinea pig maximization test (GPMT)
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of the test chemical on guinea pigs
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- 1-(4-(phenylazo)phenylazo)-2-naphthol
- EC Number:
- 201-638-4
- EC Name:
- 1-(4-(phenylazo)phenylazo)-2-naphthol
- Cas Number:
- 85-86-9
- Molecular formula:
- C22H16N4O
- IUPAC Name:
- 1-(4-(phenylazo)phenylazo)-2-naphthol
- Test material form:
- solid
- Details on test material:
- - Name of test material : 1-(4-(phenylazo)phenylazo)-2-naphthol
- Molecular formula : C22H16N4O
- Molecular weight : 352.3954 g/mol
-Smiles:c12c(\N=N\c3ccc(\N=N\c4ccccc4)cc3)c(ccc1cccc2)O
-InChI:1S/C22H16N4O/c27-21-15-10-16-6-4-5-9-20(16)22(21)26-25-19-13-11-18(12-14-19)24-23-17-7-2-1-3-8-17/h1-15,27H/b24-23+,26-25+
- Substance type: organic
- Physical state: solid powder
- Purity: 99%
- Impurities : approx 1%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Nippon Bio Supp. Center, Tokyo
- Age at study initiation: 4 weeks
- Weight at study initiation: 300 – 350 g
- Housing: housed in groups of 3 in stainless steel wire-mesh cages
- Diet (e.g. ad libitum): solid diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 2°C
- Humidity (%): 55±5%
- Air changes (per hr): 15x/h
- Photoperiod (hrs dark / hrs light): 12 h daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- (1) 0.1 ml emulsified mixture of Freund’s complete adjuvant and saline (1:1);
(2) 0.1 ml of 0.1% chemicals in olive oil
(3) 0.1 ml of the 0.1% test substance in FCA and saline mixture (1:1). - Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5 g of 1.0% test chemicals in petrolatum
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.03 ml
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- other: the highest soluble concentrations were used
- No. of animals per dose:
- Total=6
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections
- Exposure period: no data
- Test groups: 6 animals
- Control group: not specified
- Site: 2x4 cm clipped neck
- Frequency of applications: not specified
- Duration: not specified
- Concentrations: 0.1 ml of 0.1% test material
B. INDUCTION EXPOSURE
- No. of exposures: not specified
- Day(s) of induction: on day 7
- Exposure period: 48 hrs
- Test groups: 6 animals
- Control group: not specified
- Site: 2x4 cm clipped neck
- Concentrations: 0.5 g of 1.0% test chemical
C. CHALLENGE EXPOSURE
- No. of exposures: not specified
- Day(s) of challenge: 1
- Exposure period: 72 hrs
- Test groups: 6 animals
- Control group: not specified
- Site: flank regions
- Concentrations: 0.03 ml in acetone
- Evaluation (hr after challenge): 48 h
OTHER: In order to enhance the sensitization, sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction. - Challenge controls:
- vehicle control used
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.03 ml in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- In Sudan III-induced animals, no positive reaction was elicited at 0.1% concentrations
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No positive reaction was elicited at 0.1% concentrations
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The skin sensitization potential of the test chemical was evaluated on 6 Female Hartley strain albino guinea pigs.
No positive reaction was elicited at the concentrations tested. Hence, the test chemical was considered to be not sensitizing to guinea pig’s skin. - Executive summary:
Magnusson & Kligman guinea pig maximization test (GPMT) was conducted on six Female Hartley strain albino guinea pigs to assess the dermal sensitization potential of the test chemical.
Induction treatment consisted of 3 intra-dermal injections and one topical induction. On day 0, a row of 3 injections of 0.1 ml test material emulsified mixture of Freund’s complete adjuvant and saline (1:1) in olive oil was given on each side of the 2x4 cm clipped neck . In order to enhance the sensitization, sodium lauryl sulfate 10% in petrolatum was applied on induction area for 24 h before the topical induction. On day 7, 0.5 g of 1.0% test chemicals in petrolatum were occlusively applied for 48 h. The samples were covered with lint pads which were lining with Blenderm tape.
The challenge treatment was given by open topical application. On day 21, the flank regions of the animals were clipped and shaved, and then 0.03 ml of test material in acetone was applied to the skin for 72 hrs. Observations were made 48 hrs after challenge. No positive reaction was elicited at the concentrations tested.
Hence, the test chemical was considered to be not sensitizing to guinea pig’s skin.
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