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Diss Factsheets
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EC number: 207-586-9 | CAS number: 482-89-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 16 January to 19 February 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study. The test substance is leukoindigo, the reduced form of the registered substance indigo. The leucoindigo is precipitated by neutralising of the alkaline leucoindigo solution with CO2 and mixed with molasses to prevent the leucoindigo from oxidation to indigo (CAS number 482-89-3 )
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- [2,2'-bi-1H-indole]-3,3'-diol
- EC Number:
- 229-449-2
- EC Name:
- [2,2'-bi-1H-indole]-3,3'-diol
- Cas Number:
- 6537-68-4
- IUPAC Name:
- 2,2'-biindole-3,3'-diol
- Details on test material:
- - Name of test material (as cited in study report): Indigo white 50% paste
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, UK
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 292 to 379 g
- Housing: 4/cage
- Diet: guinea pig FD1 diet, Special Diet Services Ltd., Essex, UK ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 45-55
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 January to 19 February 1987
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.5%
Epicutaneous induction: undiluted as supplied
Epicutaneous challenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.5%
Epicutaneous induction: undiluted as supplied
Epicutaneous challenge: 25%
- No. of animals per dose:
- Control group: 10
Dose group: 20 - Details on study design:
- RANGE FINDING TESTS:
up tp 2 dose levels for each application were tested in each 1 or 2 guinea pigs
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 dermal
- Exposure period: occlusive dressing: 48 hours
- Test groups: TS in distilled water/FCA or undiluted
- Control group: distilled water/FCA
- Site: shoulder
- Frequency of applications: single
- Intradermal injections: 2 x 3 preparations: 50% FCA, 0.5% TS in distilled water, 0.5% TS in 50% FCA - treatment group
50% FCA, distilled water, 50% FCA - control group
- Dermal application: 0.2-0.3 mL undiluted TS (40x20 mm patch) occlusive for 48 hour
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: TS + water
- Control group: TS + water
- Site: right flank: TS; left flank: water
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours
SCORING:
0 - no reaction
1 - scattered mild redness
2 - moderate and diffuse redness
3 - intense redness and swelling
EVALUATION of RESPONSE:
0% - non-sensitizer
> 0-8% - weak sensitizer
>8-28% - mild sensitizer
>28-64% - moderate sensitizer
>64-80% - strong sensitizer
>80-100% - extreme sensitizer - Challenge controls:
- intraindividual in TS and control animals
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Clinical observations:
- blue staining of skin/hair not preventing erythema assessment
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 5.0. Total no. in groups: 19.0. Clinical observations: blue staining of skin/hair not preventing erythema assessment.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 19
- Clinical observations:
- blue staining of skin/hair not preventing erythema assessment
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 19.0. Clinical observations: blue staining of skin/hair not preventing erythema assessment.
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- blue staining of skin/hair not preventing erythema assessment
- Remarks on result:
- other: Reading: other: 1st and 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: blue staining of skin/hair not preventing erythema assessment.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Positive skin reactions were found in 5 animals ( 4 x score 1, 1 x score 2) at the 24-hour and in 4 animals (4 x score 1) at the 48-hour assessment.
According to the evaluation system used in this study, the test item was classified as "mild sensitizer". According to the EU evaluation system the test item has no sensitizing properties.
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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