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Diss Factsheets
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EC number: 223-460-6 | CAS number: 3905-19-9
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline-study performed under QAU Deficiencies: - no details on the composition of the adjuvant mixture - exact guideline was not mentioned ("...study was carried out as recommended in the OECD guidelines 1981....") - diet supplementation with ascorbic acid is equivocal - no details on the pilot/range finder study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- no details on the composition of the adjuvant mixture; exact guideline was not mentioned ("..study was carried out as recommended in the OECD guidelines 1981...."); diet supplementation with ascorbic acid is equivocal; no details on the pilot/range finder
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed in 1985, the LLNA did not yet exist.
Test material
- Reference substance name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- EC Number:
- 275-639-3
- EC Name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Cas Number:
- 71566-54-6
- Molecular formula:
- C50 H42 Cl2 N6 O8
- IUPAC Name:
- diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: powder
- Analytical purity: commercial grade
- Batch No.: EN 94903.52
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: in-house breeding
- Age at study initiation: about 10 weeks
- Weight at study initiation: 303-426 g
- Housing: individually
- Diet (ad libitum): standard guinea pigs pellets - NAFAG No. 846, Gossau SG
- Water (ad libitum): fresh water, supplemented with fresh carrots
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil (intradermal induction), vaseline (epicutaneous application)
- Concentration / amount:
- intradermal induction: 1%
epicutaneous induction: 30% (about 0.4 g/patch)
challenge: 10% (about 0.2 g/patch)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil (intradermal induction), vaseline (epicutaneous application)
- Concentration / amount:
- intradermal induction: 1%
epicutaneous induction: 30% (about 0.4 g/patch)
challenge: 10% (about 0.2 g/patch)
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- RANGE FINDING TESTS: The concentrations of the test compound for induction and challenge periods were determined on separate animals (no further information).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal exposure (Day 1) and 1 epicutaneous exposure (one week later)
- Exposure period: Day 1: 2 intradermal injections; Readings: 24 hours after the beginning of application. After one week: 48 hours epicutaneous exposure.
- Test groups: Intradermal: Each two injections: A) front row: 0.1 ml mixture adjuvant and saline; B) middle row : 0.1 ml of the test substance formulation in sesame oil; C) back row : 0.1 ml of the test substance formulation in the adjuvant saline mixture
Epicutaneous: about 0.4 g of the test substance incorporated in vaseline under an occlusive dressing, duration of exposure 48 hours; Readings 48 hours after the beginning of application. The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).
- Control group: Intradermal: same injections (A, B, C) but without test substance. Epicutaneous: Animals were treated analogously to the test group, but only with the solvent.
- Site: neck
- Frequency of applications: 2 intradermal injections and 1 epicutaneous exposure (see above)
- Duration: Day 1 (intradermal injection) – after one week (epicutaneous exposure)
- Concentrations: 1 % of the test substance with intradermal induction; 30 % of the test substance with epicutaneous application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 days after intradermal injection
- Exposure period: 24 hours
- Test groups: about 0.2 g of the test substance (flank) under an occlusive dressing.
- Control group: animals were treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals (no further information).
- Site: flank (the application sites where chemically depilated 3 hours before examination (Veet, about 5 minutes))
- Concentrations: 10 % of the test substance
- Evaluation (hr after challenge): 24, 48 hours after removal of the patch
OTHER: The test was carried out according to the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52, 268-276, 1969). - Positive control substance(s):
- yes
- Remarks:
- p - phenylenediamine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
After occlusive epicutaneous administration, no skin reactions were found in the control and test groups.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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