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EC number: 231-411-5 | CAS number: 7538-59-2
- 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 sensitisation
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
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:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on guinea pigs and humans to determine the potential of skin sensitization caused by the chemical. - GLP compliance:
- not specified
- Type of study:
- other: not specified
- Justification for non-LLNA method:
- not specified
- Specific details on test material used for the study:
- - Name of test material: barium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Molecular formula: C18H14N2O6S.Ba
- Molecular weight: 521.697 g/mol
- Smiles notation: [Ba+2].c1c(c(c(c2ccccc12)\N=N\c1c(cc(cc1)C)S(=O)(=O)[O-])O)C(=O)[O-]
- InChl: 1S/C18H14N2O6S.Ba/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;
- Substance type: Organic
- Physical State: Solid - Species:
- other: 2. humans 3. guinea pig
- Strain:
- other: 2. not applicable 3. Ibm: GOHI
- Sex:
- female
- Details on test animals and environmental conditions:
- 2. not specified
3. No data available - Route:
- other: epicutaneous
- Vehicle:
- water
- Remarks:
- 2
- Concentration / amount:
- 20%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: 1% CMC and in an emulsion of FCA/physiological saline
- Remarks:
- 3
- Concentration / amount:
- intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
- Day(s)/duration:
- no data available
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% CMC and in an emulsion of FCA/physiological saline
- Remarks:
- 3
- Concentration / amount:
- Epidermal induction: 25% dilution in 1% CMC
- Day(s)/duration:
- 18 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- other: epicutaneous
- Vehicle:
- water
- Remarks:
- 2
- Concentration / amount:
- 20%
- Day(s)/duration:
- 7 days
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% CMC and in an emulsion of FCA/physiological saline
- Remarks:
- 3
- Concentration / amount:
- Challenge: 25% dilution in 1% CMC
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2. Total = 15 patients
3. Total:15 female Test group:10 control group:5 - Details on study design:
- 2. The dye was applied in Finn Chambers and 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.
3. RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 18hr
- Test groups: 10
- Control group: 5
- Site: nuchal region
- Frequency of applications: On day 1 and 8
- Duration: 1 week
- Concentrations:for the intradermal induction: 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline.
For epidermal induction :25% in 1% CMC
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 24hr
- Test groups: 10
- Control group: 5
- Site: nuchal region
- Concentrations: 25% in 1% CMC
- Evaluation (hr after challenge): 24 and 48 hr
OTHER : The pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item during epidermal induction. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS.Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. - Challenge controls:
- 2. no data available
3. yes - Positive control substance(s):
- yes
- Remarks:
- 2. not specified 3. 2-mercaptobenzothiazole
- Reading:
- 1st reading
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- None of the treated patients showed allergic contact dermatitis.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non sensitizer in Control Group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non sensitizer in Control Group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- non sensitizer in Test Group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- non sensitizer in Test Group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- 3
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
- Executive summary:
The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on15 patients in Finn Chambers and 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.
The above study was supported with another Maximization test performed on guinea pigs to assess the dermal sensitization potential of the test chemical. The study was conducted in accordance with OECD 406 Guidelines. 15 female guinea pigs were used for the study (10 -test group, 5- control group). The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed. Hence the test chemical was considered to be not skin sensitizing in guinea pig.
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on15 patients in Finn Chambers and 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.
The above study was supported with another Maximization test performed on guinea pigs to assess the dermal sensitization potential of the test chemical. The study was conducted in accordance with OECD 406 Guidelines. 15 female guinea pigs were used for the study (10 -test group, 5- control group). The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No skin sensitization reaction was observed. Hence the test chemical was considered to be not skin sensitizing in guinea pig.
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
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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