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EC number: 283-892-6 | CAS number: 84775-63-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Indigofera tinctoria, Leguminosae.
- 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
Skin irrtitation: All animals revealed very slight oedema and erythema (score 1) after 1 h. Only one very slight
erythema remained in 1 animal after 24 h, and scoring at all further time-points was negative for all parameters.
Eye irritation:
The tested material induced significant damage to the rabbit eye and is considered to be irritating
to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: SCCS opinion/ 1439/11
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Guideline: OECD 404 (1992)
Species: New Zealand white rabbits
Group size: 3 females
Test substance: DA 060492 (Indigofera tinctoria leaf powder)
Batch: type 210741, 03.02.94.
Purity: /
Dose levels: approx. 80 mg/cm²
Route: dermal
Exposure: 4 h
GLP: in compliance
Date: 1994 - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- A cellulose patch with 0.5 g of DA 060492 was spread over approx. 6 cm² and fixed with a
non-irritating tape. Animals were examined for erythema/eschar and oedema as well as for
local and systemic signs: 1, 24, 48 and 72 h after patch removal. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- < 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All animals revealed very slight oedema and erythema (score 1) after 1 h. Scoring at all further time-points was negative for all parameters. Indigo powder is considered as non-irritating to the skin in this test.
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:
- other: SCCS Opinion /1439/11
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- not specified
- Principles of method if other than guideline:
- DA 060492 was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second. The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp. The left eye served as the control.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- not specified
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- Group size: 3 females
Test substance: DA 060492 (Indigofera tinctoria leaf powder)
Batch: type 210741, 03.02.94
Purity: /
Dose levels: 47, 73, 71 mg, applied to animals 1, 2, and 3 respectively
- Duration of treatment / exposure:
- The sample was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second.
- Observation period (in vivo):
- The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- DA 060492 was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second. The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp. The left eye served as the control.
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2,3
- Time point:
- other: 1 h
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 6 d
- Reversibility:
- not reversible
- Remarks on result:
- other: not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- other: Redness
- Basis:
- animal: 1,2,3
- Time point:
- other: 1 h
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: Not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 6 d
- Reversibility:
- not reversible
- Remarks on result:
- other: Not specified
- Remarks:
- quantitative score not available, qualitative results referenced
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2
- Time point:
- other: 6 d
- Reversibility:
- fully reversible
- Remarks on result:
- other: not specified
- Remarks:
- Qualitative results reported
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Redness and chemosis were observed in 3 animals each 1 h after exposure to Indigofera ticntoria leaf powder(DA 060492) .
No alterations of cornea and iris were observed at this time-point, but scoring at later timepoints revealed corneal opacity in 2 animals. Redness and chemosis remained for several hours, and aggravated occasionally. Additional scoring after 6 and 8 days revealed no corneal opacity, but conjunctival redness and chemosis remained for 6 days in one animal.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irrtitation, not classified. All animals revealed very slight oedema and erythema (score 1) after 1 h. Scoring at all further time-points was negative for all parameters. Indigo powder is considered as non-irritating to the skin in this test.
Eye irritation: Classified 2.
Redness (score 1 and 2) and chemosis (score 2 and 4) were observed in 3 animals each 1 h after
exposure to indigo powder. No alterations of cornea and iris were observed at this time-point, but
scoring at later time-points revealed corneal opacity in 2 animals. Redness and chemosis
remained for several hours, and aggravated occasionally. Additional scoring after 6 and 8 days
revealed no lesions of skin, but conjunctival redness and chemosis remained for 6 days in one
animal.
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