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EC number: 224-924-0 | CAS number: 4553-89-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenicity And Embryotoxicity Study Of Brown Ht In The Rat
- Author:
- D. Grant And I. F. Gaunt
- Year:
- 1 987
- Bibliographic source:
- Fd Chem. Toxic. Vol. 25, No. 12, pp. 1009-1011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Teratogenicity and Embryotoxicity Study of Brown Ht (CAS No.4553-89-3) orally in rat
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- EC Number:
- 224-924-0
- EC Name:
- Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- Cas Number:
- 4553-89-3
- Molecular formula:
- C27H20N4O9S2.2Na
- IUPAC Name:
- disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium 4,4’-(2,4-dihydroxy-5- hydroxymethyl-1,3-phenylene bis-azo) di- (naphthalene-1-sulfonate)
- Molecular formula: C27H20N4O9S2.2Na
- Molecular weight: 654.58 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: Overnight
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy Vaginal plug or sperm, referred to as day 0 of pregnancy
- Any other deviations from standard protocol: - Additional animals were treated at each dose level to replace those that failed to conceive. - Frequency of treatment:
- Daily
- Duration of test:
- 19 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500 and 1000 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- Total: 120
0 mg/kg/day: 30 femle
250 mg/kg/day: 30 femle
500 mg/kg/day: 30 femle
1000 mg/kg/day: 30 femle - Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Body weight and Body weight gain, clinical sign and gross abnormalities were examined
- Ovaries and uterine content:
- corpora lutea, implantations , Pre- implantation losses, early and late resorption, Post- implantation losses and live fetous were examined
- Statistics:
- Stsatistical analysis were done by using Student’s t test for all parameters except for the number of females with post – implantation losses for which chi-square test were used.
- Historical control data:
- In preliminary study groups of 10 female rats received daily doses of Brown HT in the concentration of 0, 250, 500 and 1000 mg/kg bw/day for 19 consecutive days. In treated rates body-weight gain were similar in all groups and no signs of toxicity were observed throughout the period of treatment. The faeces of the treated animals were markedly brown, and at autopsy there was brown discoloration of lymph nodes, colon and caecum.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant change was observed in body weight and body weight gain of treated female rat as compared 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
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- The numbers of females with post-implantation losses were increased in the treated groups although this loss did not increase with increasing dose and was not significantly different from control.
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Details on maternal toxic effects:
Mortality: No data available
Clinical signs:Nodata avaialble
Body weight: No significant change was observed in body weight and body weight gain of treated female rat as compared to control.
Reproductive function: estrous cycle: No statistically significant differences were observed in the mean numbers of corpora lutea, implantations, pre- and post implantation losses and resorptions of treated female rats.
The numbers of females with post-implantation losses were increased in the treated groups although this loss did not increase with increasing dose and was not significantly different from control.
Reproductive performance: No significant effect was observed on number of live fetuses, foetal numbers and sex ratio of treated rat as compared to control.
Gross pathology: No data available
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- No statistically significant differences were observed in foetal weight of treated rats.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- No effect was observed on number of live fetuses of treated rat.
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- effects observed, treatment-related
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Mortality:
No effect was observed on number of live fetuses of treated rat.
Body weight:
No statistically significant differences were observed in foetal weight of treated rats.
Reproductive performance:
No statistically significant differences were observed on sex ratio of fetuses of treated rat as compared to control.
Gross pathology:
When treated with 1000 mg/kg bw/day, Bicentral ossification of 1st sternebra, presences of Fourteenth ribs, One thoracic vertebra & ribs absent, Forelimb proximal phalanges ossified, Metacarpals ossified of third and fourth skeleton were observed in fetuses of treated rat.
When treated with 500 mg/kg bw/day, Bicentral ossification of 1st and 2nd sternebra, Small second sternebra, One thoracic vertebra & ribs absent and Incomplete ossification of supra-occipital of skeleton were observed in foetuses.
When treated with 250 mg/kg bw/day, Small second sternebra, presences of fourteenth ribs and Incomplete ossification of supra-occipital of skeleton were observed in foetuses.
Histopathology:
When treated with 250 mg/kg bw/day, Renal pelvis enlargement and exencephaly of the cerebrum with lateral ventricle dilation in a foetus were observed in soft-part of treated rat as compared to control.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw /day for F0 and F1 generation when Wistar female rats treated with Brown HT (Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate).
- Executive summary:
In aTeratogenicity and Embryotoxicity study,Wistar female rats treated with Brown HT (Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) in the concentration of 0, 250, 500 and 1000 mg/Kg bw/day. No significant changes were observed on body weight, mean numbers of corpora lutea, implantations, pre- and post implantation losses, resumptions,number of live fetuses,foetal numbers and sex ratio of treated female rat as compared to control.
The numbers of females with post-implantation losses were increased in the treated groups although this loss did not increase with increasing dose and was not significantly different from control.In addition, no effect was observed on number of live fetuses and foetal weight of treated female rats as compared to control. Ossified sternebrae, Bicentral ossification, Small second sternebra, presences of fourteenth ribs, One thoracic vertebra & ribs absent, forelimb proximal phalanges and Metacarpalsossified and incomplete ossification of supra-occipital gross changes were observed in foetus.Renal pelvis enlargement and exencephaly of the cerebrum with lateral ventricle dilation in a foetus were observed also observed in foetus.
The observed effects are minor deviations from normal and are of doubtful toxicological significance.
Therefore,NOAEL was considered to be 1000 mg/kg bw /day for F0 and F1 generation whenWistarfemale rats treated with Brown HT orally by gavage for 19 days.
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