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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Indigo has no irritating potential to skin or mucous membranes
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP study; Comparable to guideline study; limited information on test itemand its formulation and animal husbandry. Test are in concordance with those recommended by the ETAD. The study results are considered valid for indigo.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA Federal Register 38, No 187
- Principles of method if other than guideline:
- Patch test technique on abraded and intact skin
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- single housed
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg pasted with water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- immediately after removal (24 hours after application) and 48 hours after removal (72 hours after application)
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- Coverage: - shaved and scarified skin: 2.5x2.5 cm
- shaved skin: 2.5x2.5 cm
- Type of wrap if used: rubber sheeting
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours with cotton wool and warm water
SCORING SYSTEM: FDA Federal Register 38, No 187
Erythema and eschar formation (EEF) :
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation (EF):
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exp.) 4
Calculation of Primary Irritation Indey for intact and abraded skin.
Mean value of 6 animals
Primary Irritation Index (PII) = Animal 1 (EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved) + .... + Animal 6 (EEF24h-abraded + EEF72h-abraded + EEF24h-shaved + EEF72h-shaved + EF24h-abraded + EF72h-abraded + EF24h-shaved + EF72h-shaved)/ 24
EVALUATION:
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- not irritant
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- The application of Indigo N Lumps to intact and abraded skin for 24 hours did not lead to any signs of skin irritation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited data on test substance
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Federal Register 38, No 187
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
readings at 1, 24, 48, 72 hours after instillation - Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: -
SCORING SYSTEM:
see Tab. 1 and Tab. 2
Index for Assessment
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.9
- Max. score:
- 110
- Remarks on result:
- other: Initial pain reaction: 2
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Indigo N Lumps should not cause significant eye irritation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
No adverse effects indicative for respiratory irritation were noted in acute inhalation studies in rats.
Justification for classification or non-classification
No irritating effects observed.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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