Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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

Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline stud< and GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- EC Number:
- 291-454-0
- EC Name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- Cas Number:
- 90411-76-0
- Molecular formula:
- Mixture of components, no definitve molecular formula existing.
- IUPAC Name:
- Complex mixture of phenazine dyes - IUPAC name not available
- Test material form:
- other: solid
- Details on test material:
- content: 80.7 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation:
---males: 185g (174-193 g)
---females: 139 g (132-149g)
- Fasting period before study:
- Housing: in groups of 2-3 animals per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light) 12/12:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- groups of male and female Wistar rats recieved daily doses of the test item by gavage
(males 30 days and females 31 days) ;the test item was dissolved in water; the administration volume was 10 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- anylysis for stability and homogenicity
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
- Duration of test:
- 4 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- groups of male and female rats received daily doses of the test item which was dissolved ibn water, Treatment time for males included 30 days and for females 31 days. Animals were observed twice daily for mortality and morbidity, once daily for cliinical signs and were weighed, food and water consumption weekly
- Statistics:
- Dunnett-test, Dunnett exact homogenous test and heterogenous after logarithmic transformation, adjusted Mann-Whitney-U-test, Bonferroni Mann-Whitney U-test
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- other: NOAEL (general toxicity)
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: the treatment related slight discolorations are due to the staining property of the test item
- Remarks on result:
- other:
- Remarks:
- Daily oral treatment of rats with Nigrosin WLF at doses of 0, 100, 300, 1000 mg/kg b.w./day b.w. for a period of 4 weeks resulted in some black or grey green discolorations of feces/some tissues (predominantly in the lymph nodes, and less frequently in the intestine and/or Peyer's patch). All discolorations were considered to be due to the staining properties of the test item, except in small intestinal villi or other lymph nodes, which were not considered to be clearly test substance-related. In view of the very limited degree of changes, and as any indication of structural change or functional impairment of the organs concerned was lacking, they were considered to be non-adverse.
- Dose descriptor:
- other: NOAEL (reproductive organs)
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Observed effects
For reproductive organs.
No adverse effects observed
Applicant's summary and conclusion
- Executive summary:
100, 300 and 1000 mg/kg bw/day Nigrosin WLF dissolved in tap water, was administered orally by gavage to 5 male and 5 female Wistar rats per dose group for a period of 4 weeks according to OECD TG 407 and GLP in which also the effects on reproductive organs are examined.. For general toxicity see ther respective section of repeated dose toxicity. With regard to the reproductive organs no adverse effects are observed . Therefore, the NOAEL (reproductive toxicity) is considered 1000 mg/kg bw/day
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
