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EC number: 291-454-0 | CAS number: 90411-76-0
- 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
Nigrosin WLF is not irritating to the skin and not to the mucous membranes of the eyes
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: equivalent to OECD guideline study but no GLP: test substance was applied to the inner surface of the rabbit's ear instead to the rabbits's back
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD Subkommitee für Toxikologie: : Empfohlene Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln"
- Principles of method if other than guideline:
- On the inner surface of one ear of each of 2 New Zealand White rabbits test substance was applied and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- body weight at the start of the study: 3-4 kg
one male and one female rabbit
housing individually
diet ad libitum
water ac libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: no preparing necessary
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite ear served as contol
- Amount / concentration applied:
- 500 mg/animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days post treatment
- Number of animals:
- 2
- Details on study design:
- On the inner surface of one ear of each of 2 New Zealand White rabbits test substance was applied and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h - 7 d
- Score:
- ca. 0
- Max. score:
- 8
- Reversibility:
- other: no effects observed
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- other: not determined
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- other: not determined
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- other: not determined
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- other: not determined
- Irritant / corrosive response data:
- not irritating
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Instead of to the back of rabbits test substance was applied to the inner surface of one ear of each of
2 New Zealand White rabbits and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control. No reaction of the skin was observed. Thus, Nigrosin WLF has to be evaluated as not irritating to the skin.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similiar to OECD guideline (instillation of only 50 mg , not 100 mg), no GLP
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD-Subkomitee für Toxikologie: Empfohlenen Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln
- Principles of method if other than guideline:
- Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- body weight at the start of the study: 3-4 kg
one male and one female rabbit
housing individually
diet ad libitum
water ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the opposite eye served as contol
- Amount / concentration applied:
- 50 mg/animal
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days., the opposite eye served as control.
- Irritation parameter:
- overall irritation score
- Basis:
- animal:
- Time point:
- other: up to 7 days
- Score:
- ca. 0
- Max. score:
- 110
- Remarks on result:
- other: no irritation was observed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- no reactions were observed
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Application of 50 mg and not 100 mg test substance into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
SKIN IRRITATION
Instead of to the back of rabbits test substance was applied to the inner surface of one ear of each of 2 New Zealand White rabbits and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control. No reaction of the skin was observed. Thus, Nigrosin WLF has to be evaluated as not irritating to the skin.
EYE IRRITATION
Application of 50 mg test substance instead of 100 mg into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.
Justification for selection of skin irritation / corrosion endpoint:
only one study available
Justification for selection of eye irritation endpoint:
only one study available
Justification for classification or non-classification
based on the available data, no classification or labelling is required
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