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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
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
(LD50 (oral, rat) > 2000 mg/kg bw: no clinical findings, no mortality
LD50 (dermal, rat) > 2000 mg/kg bw: no clinical findings, no mortality
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study report in brief, but sufficient information aviailable to be taken for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 daxs for clinical signs and mortality.
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:150-200 g
- Diet ad libitum
- Water ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 daxs for clinical signs and mortality.
- Doses:
- 1000 or 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 per dose group
- Control animals:
- no
- Details on study design:
- Single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 daxs for clinical signs and mortality. Results evaluated by Probit-analysis according to Fink and Hund, arneimittelforschung 15, 1965
- Statistics:
- Results are evaluated by Probit-analysis according to Fink and Hund, Arzneimittelforschung 15, 1965
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality, fo clinical findings
- Mortality:
- no animal died
- Clinical signs:
- other: mo clinical signs wre observed
- Gross pathology:
- no data
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
An acute oral toxicity study is available with single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 days for clinical signs and mortality. No animal died , no clinical signs were observed and body weight development was not affected by treatment. Thus the LD50 is >5000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is performed similiar to the current guideline and has Klimisch Score 2
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 402 and EEC Directive 440/2008 Part B, Method B.3
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation:
males 291-300 g
females 226-247 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%):55
- Air changes (per hr) 10:
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test substance was applied to a wet gauze layer which was then applied to the shaved area of the back of the rabbits. The patches were held in place by semi-occlusive dressing (gauze strip and a tape). After 24 hours the dressings were removed and the area was rinsed with tepid water
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- other: the opposite site of the back of each animal served as control
- Details on study design:
- The test substance was applied to a wet gauze layer which was then applied to the shaved area of the back of the rabbits. The patches were held in place by semi-occlusive dressing (gauze strip and a tape). After 24 hours the dressings were removed and the area was rinsed with tepid water. The opposite site of the back of each animal served as control. Animals were observed for clinical signs and mortality for 14 days, weight gain was checked weekly. after termination of the observation period the animals were sacrificed and examind macroscopically
- Statistics:
- Only the limit dose was tested
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Remarks on result:
- other: no death occurred and no clinical signs were reported
- Mortality:
- no animal died
- Clinical signs:
- other: no clinical sign is reported
- Gross pathology:
- no gross pathological f9nding
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
Nigrosin WLF was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semiocclusive conditions. After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- the study is a guideline study and is GLP compliant and has Klimisch Score 1
Additional information
ORAL APPLICATION
An acute oral toxicity study is available with single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 days for clinical signs and mortality. No animal died , no clinical signs were observed and body weight development was not affected by treatment. Thus the LD50 is >5000 mg/kg bw
DERMAL APPLICATION
Nigrosin WLF was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semi-occlusive conditions. After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw
INHALATION ROUTE
According to Regulation /EC) No. 1907/2006 ANNEX VIII column 2: In addition to the acute toxicity study using the oral route, for substances other than gases, at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an other study available using the dermal route: this study is performed according to respective guideline and is GLP compliant and evaluated with Klimisch Score 1. Thus, there is no need to conduct an acute toxicity study using the inhalation route..
Justification for selection of acute toxicity – oral endpoint
the only available study which is performed similiar to the current guideline
Justification for selection of acute toxicity – inhalation endpoint
According to Regulation /EC) Mo. 1907/2006 ANNEX VIII colun 2: In addition to the acute toxicity study using the oral route, for substances other than gases, at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an other study available using the dermal route: this study is performed according to respective guideline and is GLP compliant and evaluated with Klimisch Score 1. Thus, there is no need to conduct an acute toxicity study using the inhalation route.
Justification for selection of acute toxicity – dermal endpoint
Only one study available
Justification for classification or non-classification
Based on the available data no classification or labelling is required
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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