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EC number: 431-920-4 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Leuco-Indigo
- IUPAC Name:
- Leuco-Indigo
- Details on test material:
- - Name of test material (as cited in study report): Indigolösung BASF 20%
Constituent 1
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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