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EC number: 212-974-6 | CAS number: 894-86-0
- 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
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:
- weight of evidence
- Study period:
- 29-Mar to 26-Apr-1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 404 and GLP compliant. The test substance is leucoindigo in NaOH solution forming the mono- or disodium salt
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Gaukler; Offenbach
- Age at study initiation: young adult
- Weight at study initiation: 2.4 to 3.3 kg
- Housing: single
- Diet: Kliba Labordiaet 341 ca 130 g/rabbit/day
- Water: tap water ca. 250 mL/rabbit/day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 30 to 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 29-Mar to 26-Apr-1993 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- 72 hours
Readings at 1, 24, 48, 72 hours after patch removal - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: upper third of back or flanks
- Coverage: 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive (Fixomull stretch)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol:water 1:1
- Time after start of exposure: 3 minutes or 1 hour
SCORING SYSTEM: according to Draize
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema 4
Edema formation
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 exposure) 4 - Irritation parameter:
- erythema score
- Remarks:
- 3 minutes exposure
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- 3 minutes exposure
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: study was terminated at 72 hours due to skin necrosis
- Irritant / corrosive response data:
- visual necroses were observed in all animals 24 or 72 hours after application
Macroscopic examination of necrotic areas revealed superficial focal necrosis in one and full thickness necrosis in two rabbits. - Other effects:
- bluish discoloration of application site
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions chosen and considering the findings described, Indigolösung BASF 20% gives indication of severe skin damage after an exposure period of 1 hour. As Indigo itself has proven not to be an irritant, this effect is most likely due to the NaOH content of the preparation.
Reference
3 Minutes Exposure
|
Animal |
Erythema |
Edema |
Comments |
1 hour |
01 |
NA |
0 |
index for erythema could not be read because of bluish staining by the test substance |
|
02 |
1 |
0 |
skin stained by test substance |
|
03 |
1 |
0 |
skin stained by test substance |
24 hours |
01 |
2 |
0 |
skin stained by test substance |
|
02 |
2 |
1 |
skin stained by test substance |
|
03 |
2 |
1 |
skin stained by test substance |
48 hours |
01 |
1 |
0 |
skin stained by test substance |
|
02 |
2 |
0 |
skin stained by test substance |
|
03 |
2 |
0 |
skin stained by test substance |
72 hours |
01 |
1 |
0 |
skin stained by test substance |
|
02 |
1 |
0 |
scaling, skin stained by test substance |
|
03 |
2 |
0 |
scaling, skin stained by test substance |
Mean |
01 |
1.3 |
0.0 |
|
|
02 |
1.7 |
0.3 |
|
|
03 |
2.0 |
0.3 |
|
Mean |
|
1.7 |
0.2 |
|
1 Hour Exposure
|
Animal |
Erythema |
Edema |
Comments |
1 hour |
01 |
NA |
0 |
index for erythema could not be read because of bluish staining by the test substance |
|
02 |
2 |
1 |
hemorrhage,skin stained by test substance |
|
03 |
2 |
1 |
hemorrhage,skin stained by test substance |
24 hours |
01 |
3 |
2 |
hemorrhage,skin stained by test substance |
|
02 |
NA |
2 |
necrosis, skin stained by test substance |
|
03 |
NA |
1 |
necrosis, skin stained by test substance |
48 hours |
01 |
3 |
2 |
superficial scabbing, skin stained by test substance |
|
02 |
NA |
2 |
necrosis, skin stained by test substance |
|
03 |
NA |
1 |
necrosis, skin stained by test substance |
72 hours |
01 |
2 |
2 |
superficial focal necrosis, skin stained by test substance |
|
02 |
NA |
1 |
full thickness necrosis, skin stained by test substance |
|
03 |
NA |
1 |
full thickness necrosis, skin stained by test substance |
Mean |
01 |
2.7 |
2.0 |
|
|
02 |
NA |
1.7 |
|
|
03 |
NA |
1.0 |
|
Mean |
|
NA |
1.6 |
|
For calculation of the means of erythema and edema only the readings of 24, 48 and 72 hours were used
The study was discontinued after the 72-hour reading because of severe irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: BASF internal standards followed
- Principles of method if other than guideline:
- BASF internal testing method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talcum
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 144 hours
- Number of animals or in vitro replicates:
- no data
- Details on study design:
- SCORING SYSTEM:
Erythema and Edema
Ø - no effect
(+) - questionable
+ - mild
++ - moderate
+++ - marked
N - necrosis
Tr - opacity
Na - scar - Irritation parameter:
- chemosis score
- Remarks:
- see details below
- Basis:
- mean
- Time point:
- other: 24 h
- Remarks on result:
- other: Indigo : marked edema
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Remarks on result:
- other: Talcum: mild edema
- Irritant / corrosive response data:
- Indigo: 1 hour: moderate edema; blue TS remains
24 hours: marked edema, discharge; blue TS remains
144 hours: marked edema, moderate opacity, purulent discharge, white conjunctiva/nictitating membranes, encrusted eyelids
Talcum: 1 hour: mild erythema, mild edema
24 hours: mild erythema
24 hours: no effects - Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Indigoküpe 60% Körner may cause severe eye irritation. As Indigo itself proofed not to be irritating this effect is most likely due to the 5% alkali content.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data on skin and eye irritation studies show that indigo itself is not irritating to rabbit skin and eyes. Studies with a positive outcome regarding skin or eye irritation contained at least 3% NaOH/KOH.
Based on animal data it can be concluded that a NaOH solution of 8% can be considered corrosive for skin. Based on human data concentrations of 0.5–4% were irritating. In 2 different studies a concentration of 0.5% was irritating for only 55 and 61% of the volunteers, respectively and therefore it is assumed that a concentration, which is slightly lower than 0.5%, is the non-irritating concentration.
The available animal data on eye irritation of NaOH revealed small differences in eye irritation levels. The non-irritant level was 0.2-1.0%, while the corrosive concentration was 1.2% or higher than 2%.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
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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