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EC number: 286-282-8 | CAS number: 85203-90-3
- 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
Skin Sensitization:
The results of the experimental studies from the structurally similar read across substances indicate a possibility that 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated can be not sensitizing to skin.
Hence by applying the weight of evidence approach, 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Weight of evidence based on structurally similar read across chemicals
- Justification for type of information:
- Weight of evidence based on structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence based on structurally similar substances
- Principles of method if other than guideline:
- The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated- IUPAC name: 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated- Molecular formula: C40H36N4O1 - Molecular wt. : 588.76 g/mole- smiles : Cc1ccccc1N=Nc2ccc(c(C)c2)N=Nc3c4ccc(C(C)c5ccccc5)cc4cc(C(C)c6ccccc6)c3O- Substance type: Organic- Physical state: solid
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data available
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- (1) 0.1 ml emulsified mixture of Freund’s complete adjuvant (FCA: Iatron Co., Ltd., Tokyo) 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 chemical
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 ml of test chemical
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 ml of a 2% aqueous solution of a 40% color paste.
- Day(s)/duration:
- 3 times a day for 5 consecutive days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.03 ml aliquots of test chemicals in acetone
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10,5 and 2.5 % of the induction concentration
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 8% of 40% color paste.
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. total - 62. total - 103. total - not specified
- Details on study design:
- The study is based on weight of evidence approach from the read across values
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- On the basis of available studies for the structurally similar read across substances, the weight of evidence approach is applied to assess the skin sensitization potential for target substance. 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated was estimated to be not sensitizing to guinea pig skin.
- Executive summary:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the skin sensitization potential for2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated.
Magnusson & Kligman guinea pig maximization test (GPMT) was conducted (Contact Dermatitis, 2000) 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.
This is supported by the experimental study summarized in JOURNAL OF COSMETIC SCIENCE, 2007 for the structurally similar chemical. Buehler and the Klecak method for open epicutaneous testing (OET) was performed to determine the degree of dermal sensitization caused by the test chemical in guinea pigs.
During the induction phase, the left flanks of ten albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday, Friday) for three consecutive weeks.
Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentrations(10.0%, 5.0%, and 2 .5%). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.
All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale. A positive control of 0.5% 2,4-dinitrochlorobenzene(DNCB) in ethanol was included for both the induction and challenge phases.
No positive skin irritation reactions. Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
The above results are further supported by the experimental study summarized in Scientific Committee on Cosmetology (seventh series) for the structurally similar read across chemical. Guinea Pig Maximization test was performed to assess the dermal sensitization potential of the test chemical.
During the induction phase, 0.1 ml of a 2% aqueous solution of a 40% color paste of the test chemical was injected intra cutaneously three times a day for 5 consecutive days
Challenge treatment was provided 4 weeks after induction treatment in the concentration 8% of 40% color paste. No skin allergic reactions were observed in the guinea pigs. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available data for the structurally similar read across chemicals and applying the weight of
evidence approach, it can be concluded that2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenatedwill also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the skin sensitization potential for2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated.
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.
This is supported by the experimental study for the structurally similar chemical. Buehler and the Klecak method for open epicutaneous testing (OET) was performed to determine the degree of dermal sensitization caused by the test chemical in guinea pigs.
During the induction phase, the left flanks of ten albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday, Friday) for three consecutive weeks.
Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentrations(10.0%, 5.0%, and 2 .5%). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.
All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale. A positive control of 0.5% 2,4-dinitrochlorobenzene(DNCB) in ethanol was included for both the induction and challenge phases.
No positive skin irritation reactions. Hence, the test chemical was considered to be not sensitizing to guinea pig skin.
The above results are further supported by the experimental study summarized in Scientific Committee on Cosmetology (seventh series) for the structurally similar read across chemical. Guinea Pig Maximization test was performed to assess the dermal sensitization potential of the test chemical.
During the induction phase, 0.1 ml of a 2% aqueous solution of a 40% color paste of the test chemical was injected intra cutaneously three times a day for 5 consecutive days
Challenge treatment was provided 4 weeks after induction treatment in the concentration 8% of 40% color paste. No skin allergic reactions were observed in the guinea pigs. Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available data for the structurally similar read across chemicals and applying the weight of
evidence approach, it can be concluded that2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenatedwill also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the experimental studies from the structurally similar read across substances indicate a possibility that 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated can be not sensitizing to skin.
Hence by applying the weight of evidence approach, 2-naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.
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