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Diss Factsheets
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EC number: 229-246-9 | CAS number: 6448-96-0
- 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
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further 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:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Justification for non-LLNA method:
- no data available
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white petrolatum
- Concentration / amount:
- 2% in white petrolatum
- Adequacy of induction:
- not specified
- Route:
- other: epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 20% dye in water
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white petrolatum
- Concentration / amount:
- 2% in white petrolatum
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 20% dye in water
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 32 patients
2. 15 patients - Details on study design:
- The data is based on weight of evidence approach based on various test chemicals
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
- Executive summary:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.
The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.
The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.
Hence, the test chemical can be considered to be not sensitizing to skin.
This is supported by the results of another patch test performed to determine the skin sensitization potential of the test chemical.
Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water was applied on the skin of 15 patients in Finn Chambers. The skin reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.
None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical 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:
The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.
A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.
The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.
The test chemical did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers.
Hence, the test chemical can be considered to be not sensitizing to skin.
This is supported by the results of another patch test performed to determine the skin sensitization potential of the test chemical.
Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water was applied on the skin of 15 patients in Finn Chambers. The skin reactions were read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.
None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical 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
Based on the available data for the various test chemicals and applying the weight of evidence approach,it can be concluded that the test chemical will also behave in similar manner.
The test chemical was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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