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EC number: 612-023-9 | CAS number: 607724-37-8
- 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
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Long-term toxicity study of black PN in mice
- Author:
- J.J.-P. Drake, K.R. Butterworth, I.F. Gaunt, P. Grasso
- Year:
- 1 977
- Bibliographic source:
- Food and Cosmetics Toxicology Volume 15, Issue 6, December 1977, Pages 503-508
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Evaluation on the testicular toxicity and esterogenic activity of test chemical in male and female mice.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
- EC Number:
- 219-746-5
- EC Name:
- Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
- Cas Number:
- 2519-30-4
- Molecular formula:
- C28H21N5O14S4.4Na
- IUPAC Name:
- tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate
- Details on test material:
- - Name of test material (as cited in study report):Black PN- Molecular formula :C28H21N5O14S4.4Na- Molecular weight :867.6873 g/mol- Substance type:Organic
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CFW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: No data available- Age at study initiation: No data available- Weight at study initiation: yes - Fasting period before study: No data available- Housing: They were caged in groups of 15 in a room .- Diet (e.g. ad libitum): Oxoid pasteurized Breeding diet - Water (e.g. ad libitum): water available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data- Humidity (%):50-60%- Air changes (per hr): No data- Photoperiod (hrs dark / hrs light): 21 ± 1°CIN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: Oxoid pasteurized Breeding diet
- Details on exposure:
- DIET PREPARATION- Rate of preparation of diet (frequency):- Mixing appropriate amounts with (Type of food): Oxoid pasteurized Breeding diet- Storage temperature of food:VEHICLE- Justification for use and choice of vehicle (if other than water):- Concentration in vehicle: 0.1, 0.25,0.5 or 1.0%- Amount of vehicle (if gavage):- Lot/batch no. (if required):- Purity:
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- Groups of 30 male and 30 female mice were given diets containing 0.1, 0.25, 0.5 or 1.0% test chemical for 80 wk, with groups of 60 mice of each sex as controls. Effects on mortality ,body-weight gain, hematology, organ weights and histopathology was observed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 0.1, 0.25,0.5 and 1.0%Basis:nominal in diet
- No. of animals per sex per dose:
- 0%-60 male and 60 female0.1%-30 male and 30 female0.25% -30 male and 30 female0.5-30 male and 30 female1%-30 male and 30 female
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- The general condition and behavior of the animals were observed frequently and any mouse that showed signs of ill-health was isolated, to be returned to its cage on recovery or to be killed If its condition deteriorated. Body weight-The mice were weighed at the start of the experiment, at wk 3 and then at intervals of 2 wk until wk 73 of the experiment. Hematology-Blood samples were taken at wk 28 and 55 from the caudal vein of ten males and ten females from the control group and from the groups given the 0.5 and 1% dietary levels. At 80 wk, blood samples were collected from the aorta of all surviving mice during the autopsy. The samples were examined for haemoglobin concentration and packed cell volume, as well as for counts of erythrocytes and leucocytes. In addition, the methaemoglobin concentrations were determined in the samples collected at 80 wk. Preparations for counting the reticuiocytes and the different types of leucocytes were made but, in the absence of consistent effects on the other measurements, these counts were not carried out.Urine analysis-During wk 28, urine samples were collected over a 6-hr period from three groups of five mice of each sex from the controls and the groups on the two highest dietary levels (0.5 and 1%) of Black PN. These samples were examined for protein, reducing substances, bile salts and blood as well as for colour, pH and microscopic constituents. Organ weight was also measured.
- Oestrous cyclicity (parental animals):
- No data available.
- Sperm parameters (parental animals):
- No data available.
- Litter observations:
- No data available.
- Postmortem examinations (parental animals):
- The animals were killed by exsanguinations from the aorta under sodium pentobarbitone anesthesia following an overnight period without food. At autopsy, macroscopic abnormalities were recorded and the brain, heart, liver, spleen, kidneys, adrenal glands and gonads were weighed. Samples of these organs and of salivary glands, pituitary, thyroid, thymus, various lymph nodes, pancreas, urinary bladder, lungs, stomach, duodenum, ileum, colon, caecum,rectum, striped muscle (hind limb), spinal cord, uterus, aortic arch and any other tissue that appeared abnormal were preserved in 10% buffered formalin. Paraffin-wax sections of these tissues were stained with haematoxylin and eosin. All tissues from the control mice and from those fed diet containing 1% Black PN were examined histologically. At the lower dose levels, the examination was confined to the liver, kidneyand any tissues seen to be abnormal at autopsy
- Postmortem examinations (offspring):
- No data available
- Statistics:
- Statistics was observed by different method for different parameters
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 1 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect were observed on mortality ,body-weight gain, hematology, organ weights and histopathology
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Effect levels (F1)
- Dose descriptor:
- other: Not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: Not secified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Relative organ weights of mice fed diets containin# 0-1% Black PN for 80 wk
Sex /dietery level % | No. Of rats examined | Brain | Heart | Liver | Spleen | Kidney | Adrenals | Gonades | Terminal body weight |
0 | 40 | 1.07 | 0.64 | 5.47 | 0.38 | 1.67 | 27.5 | 0.45 | 35 |
0.1 | 20 | 1.21 | 0.59 | 5.84 | 0.45 | 1.50 | 27.8 | 0.41 | 36 |
0.25 | 20 | 1.15 | 0.63 | 5.88 | 0.44 | 1.62 | 27.1 | 0.45 | 33 |
0.5 | 12 | 1.32 | 0.71* | 5.80 | 0.51 | 1.77* | 29.6 | 0.49 | 32 |
1 | 23 | 1.28 | 0.63 | 5.29 | 0.39 | 1.60 | 28.5 | 0.48 | 35 |
Female | |||||||||
0 | 32 | 1.53 | 0.57 | 5.80 | 0.51 | 1.46 | 40.6 | 84.2 | 29 |
0.1 | 11 | 1.53 | 0.61 | 5.87 | 0.56 | 1.56 | 37.8 | 84.8 | 28 |
0.25 | 17 | 1.72 | 0.64* | 5.29 | 0.41 | 1.51 | 45.9 | 100.8 | 26 |
0.5 | 15 | 1.55 | 0.56 | 5.43 | 0.54 | 1.41 | 42.8 | 101.2 | 27 |
1 | 18 | 1.53 | 0.53 | 5.27 | 0.47 | 1.40 | 42.3 | 87.2 | 30 |
Weights are expressed in mg/100g body weight. Weights of female gonads only are expressed in mg/100g body weight. Values are means for the numbers of mice shown and those marked with an asterisk differ significantly (Student's t test) from those of controls: *P < 0.05. |
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1300 mg/kg/day for test chemical in male and femle CFW mice for 80 weeks by oral feed.
- Executive summary:
Reproductive study was conducted for test chemical in male and female CFW mice for 80 weeks by oral feed. When Groups of 30 male and 30 female CFW mice were given diets containing 0.1, 0.25, 0.5 and 1.0% test chemical for 80 wk, with groups of 60 mice of each sex as controls.There were no dose-related effects on body-weight gain, haematology and organ weights. The incidence of histopathological findings was not altered by the feeding of test chemical. Therefore it is considered that test chemical to the diet of male and female CFW mice at levels up to 1% (equivalent to approximately 1300 mg/kg/day) for 80 wk does not induce any reprotoxic effect.
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