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EC number: 211-189-6 | CAS number: 632-99-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Data is from qualified publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- A Comparative Study of the Chronic Effects of Magenta, Paramagenta, and Phenyl-p-naphthylamine in Syrian Golden Hamsters
- Author:
- U. Green, J. Holste, and A.R. Spikermann
- Year:
- 1 979
- Bibliographic source:
- J. Cancer Res. Clin. Oncol. 95, 51-55 (1979)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the toxic nature of Magenta in male and female Hamster by oral gavage for 88 weeks.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- EC Number:
- 211-189-6
- EC Name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- Cas Number:
- 632-99-5
- Molecular formula:
- C20H19N3.ClH
- IUPAC Name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- Details on test material:
- IUPAC name:((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl
Constituent 1
- Specific details on test material used for the study:
- IUPAC name:Magenta
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl
Test animals
- Species:
- hamster, Syrian
- Strain:
- other: Syrian golden
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: derived from an outbred colony (Coombehurst, Baughurst, England),
- Age at study initiation: 12 weeks
- Weight at study initiation: Not specified
- Fasting period before study: Not specified
- Housing: housed, sex segregated, 5 to a cage in
plastic cages
- Diet (e.g. ad libitum): Pelleted diet (RMH-B, Hope Farms, Woerden, The Netherlands, ad libitum
- Water (e.g. ad libitum): water ad libitum.
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2(°C
- Humidity (%):50 +_ 5%
- Air changes (per hr): 20 times per hour
- Photoperiod (hrs dark / hrs light): Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: NaCl solution.
- Details on oral exposure:
- Details on oral exposure
VEHICLE
- Justification for use and choice of vehicle (if other than water): Since magenta dissolve only a little in water and may not be reabsorbed by the intestinal tract, the effect which was seen in the subcutaneous tissue of rats could well be associated with the physical properties of the compounds
- Concentration in vehicle: 400 and 600 mg/kgbw/day
- Amount of vehicle (if gavage): 0.9% - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 88 weeks
- Frequency of treatment:
- Twice weekly for life
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kgbw/day
- Dose / conc.:
- 400 other: mg/kgbw/day
- Dose / conc.:
- 600 other: mg/kgbw/day
- No. of animals per sex per dose:
- Total number of animals 240 animals
0 mg/kgbw/day,40 male and 40 females
400 mg/kgbw/day,40 male and 40 females
600 mg/kgbw/day,40 male and 40 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule:Twice daily wice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY ; Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
OTHER: - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes, Complete autopsies were
performed on all animals and the organs were fixed in 10% buffered formalin.
HISTOPATHOLOGY: Yes Paraplast sections were stained with haematoxylin and eosin and by the van Gieson method. Step sections were prepared from the urinary tract. - Statistics:
- For statistical evaluation, only those animals were considered, which had all organs histologically examined (effective number of animals).
Survival data are from the beginning of treatment.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant effect like haemorrhagic enteritis, stomach ulcers and diarrhoea were observed at the dose level of 600 mg/kgbw/day in treated group compare to control.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- The majority of treatment animals of 600 mg/kgbw/day dose group died within the first 10 weeks of treatment compare to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant weight loss were observed at the dose level of 600 mg/kgbw/day in treated group compare to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant effects were observed at the 400 mg/kgbw/day of treated group compare to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at the 400 mg/kgbw/day of treated group compare to control.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Age-dependent alterations included amyloidosis of the kidneys, liver and spleen.The overall tumor incidences for magenta was 5%. Average survival times of tumor bearing animals for magenta was 68 weeks and NaCl controls was 55 weeks. The urinary tract was free of neoplastic growth. Tumors found in the treated groups and not seen in the controls were either isolated observations or known from historic controls. No significant tumour were observed for test substance maganta.
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 400 other: mg/kgbw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were observed at this dose level.
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 400 mg/kgbw/day for Magenta in male and female Hamster by oral gavage for 88 weeks.
- Executive summary:
In a Repeated dose toxicity study for Magenta was conducted in male and female Syrian golden Hamster for 88 weeks by oral gavage.The animals were exposed twice weekly to 0,400 and 600 mg/kgbw/dayoftest substance. In high dose level groups 600 mg/kg b.w. the majority of animals died within the first 10 weeks of treatment.They showed a rapid weight loss, haemorrhagic enteritis, stomach ulcers, and diarrhoea. The data clearly indicate that these dose levels were not tolerated by the Syrian golden hamsters. On the other hand, the lower doses (400 mg/kg was well-tolerated and the body weight developments of these groups were similar to those of the controls, as were the average survival times. Macroscopic alterations and microscopic lesions were similar in experimental and control hamsters, and were not associated with treatment. Age-dependent alterations included amyloidosis of the kidneys, liver and spleen. The overall tumor incidences was 5%;. Average survival times of tumor bearing animals was 68 weeks while NaCl controls, 55 weeks. The urinary tract was free of neoplastic growth.Tumors found in the treated groups and not seen the controls were either isolated observations or known from historic controls.As no significant effect were observed at the doe level of 400mg/kgbw/day. Therefore NOAELwas considered to be 400mg/kgbw/day for Magenta in male and female Hamster by oral gavage for 88 weeks.
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