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EC number: 245-821-7 | CAS number: 23680-84-4
- 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 Amino Nitrophenols as Used in Hair Dyes
- Author:
- Burnett CL, Bergfeld WF, Belsito DV, Klaassen CD, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Alan Andersen F.
- Year:
- 2 009
- Bibliographic source:
- International Journal of Toxicology 2009;Nov-Dec;28(6 Suppl 2):217S-51S.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The sensitizing potential of 4-amino-3-nitrophenol (CAS no: 610-81-1) was studied in a guinea pig maximization study on female Hartley albino guinea pigs (5 in a control group, 10 in the test group).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 1-Hydroxy-3-nitro-4-aminophenol
- Cas Number:
- 610-81-1
- Molecular formula:
- C6H6N2O3
- IUPAC Name:
- 1-Hydroxy-3-nitro-4-aminophenol
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): 4-amino-3-nitrophenol
- Molecular formula : C6H6N2O3
- Molecular weight : 154.124 g/mole
- Substance type: organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4-amino-3-nitrophenol
- Molecular formula : C6H6N2O3
- Molecular weight : 154.124 g/mole
- Substance type: organic
- Physical state: solid
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)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: distilled water
- Concentration / amount:
- 3 symmetrical intradermal injections of 0.1 mL that consisted
•Freund’s complete adjuvant (FCA) and distilled water (1:1 vol/vol),
•4-amino-3- nitrophenol diluted to 10% in distilled water, and
•4-amino-3- nitrophenol diluted to 10% in mixture 1:1 (vol/vol) with FCA and distilled water. - Day(s)/duration:
- 6 Days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 50% (0.5mL)
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: the maximal nonirritant concentration
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.2ml
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: the maximal nonirritant concentration and a lower concentration were applied to all animals for a period of 24 hours.
- No. of animals per dose:
- 15 (5 in a control group, 10 in the test group)
- Details on study design:
- RANGE FINDING TESTS: A preliminary test was conducted to determine the maximal nonirritant concentration.
A. INDUCTION EXPOSURE: intradermal
- No. of exposures: 1
- Exposure period: : 6 days
- Test groups:10
- Control group: : 5
- Site: : clipped dorsal
- Frequency of applications: no data
- Duration: : 6 days
- Concentrations: 3 symmetrical intradermal injections of 0.1 mL that consisted
• Freund’s complete adjuvant (FCA) and distilled water (1:1 vol/vol),
• 4-amino-3- nitrophenol diluted to 10% in distilled water, and
• 4-amino-3- nitrophenol diluted to 10% in mixture 1:1 (vol/vol) with FCA and distilled water.
A.II. INDUCTION EXPOSURE: topical
- No. of exposures:1
- Exposure period: 48 hours
- Test groups: 10
- Control group: 5
- Site: at reclipped injection sites
- Frequency of applications: no data
- Duration: 48 hours
- Concentrations: 50 % (0.5ml)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 11 days
- Exposure period: 24 hours
- Test groups: 10
- Control group: 5
- Site: clipped dorsolumbar region
- Concentrations: 0.2ml
- Evaluation (hr after challenge): after 24 and 48 hours - Challenge controls:
- Yes, concurrent vehicles were used.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization was observed in treated group.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Because of the dyeing properties of the test substance, assessment of erythema was impossible. No edematous reactions were observed. The researchers concluded that 4-amino-3-nitrophenol was not sensitizing by contact with guinea pig skin.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The chemical 4-amino-3-nitrophenol (CAS no: 610-81-1) was considered to be not sensitizing on female Hartley albino guinea pigs skin.
- Executive summary:
The sensitizing potential of 4-amino-3-nitrophenol (CAS no: 610-81-1) was studied in a guinea pig maximization study on female Hartley albino guinea pigs (5 in a control group, 10 in the test group).
During induction, the test group received 3 symmetrical intradermal injections of 0.1 mL that consisted of Freund’s complete adjuvant (FCA) and distilled water (1:1 vol/vol), 4-amino-3- nitrophenol diluted to 10% in distilled water, and 4-amino-3-
nitrophenol diluted to 10% in mixture 1:1 (vol/vol) with FCA and distilled water. Adequate controls were used.
The guinea pigs were not treated for a period of 6 days and then were reclipped at the injection sites. Because the material did not produce local irritation, the test areas of both the control and treated animals were coated with 0.5 mL of sodium lauryl sulfate at 10% in liquid petrolatum to produce irritation. After 24 hours, the treated group was patched with 0.5 mL of 4-amino-3-nitrophenol diluted to 50% for 48 hours. The control group was patched with 0.5 mL of distilled water.
After an 11-day rest period, both groups of guinea pigs were clipped on the dorsolumbar region. Occlusive patches with 0.2 mL of 4-amino-3-nitrophenol at the maximal nonirritant concentration and a lower concentration were applied to all animals for a period of 24 hours. At 24 and 48 hours after challenge patch removal, the skin was observed for cutaneous reactions.
Because of the dyeing properties of the test substance, assessment of erythema was impossible. No edematous reactions were observed. The researchers concluded that 4-amino-3-nitrophenol was not sensitizing by contact with guinea pig skin.
Therefore the chemical 4-amino-3-nitrophenol (CAS no: 610-81-1) was considered to be not sensitizing onfemale Hartley albino guinea pigs’ skin.
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