Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 265-634-4 | CAS number: 65212-77-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- read across substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (adopted 27th July 1995)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (adopted 3rd October 2008)
- Deviations:
- yes
- Remarks:
- no testing of the endocrine system
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EEC of September 30, 1996, Part B, 1996
- Qualifier:
- according to guideline
- Guideline:
- other: Japan/MHW 1987
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate
- EC Number:
- 265-633-9
- EC Name:
- Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate
- Cas Number:
- 65212-76-2
- Molecular formula:
- C16H12Cl2N4O7S2.2Na
- IUPAC Name:
- disodium 4,5-dichloro-2-{[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- breeder: Charles River, Sulzfeld, Germany
age: 36 +/- 1 days
body weight: app. 153 g male, 126 g female
acclimatization period: 5d
The rats were housed singly in a fully air-conditioned room.
Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity.
The day/night rhythm was 12 hours (12 hours light from 06.00 a.m. - 06.00 p.m., 12 hours dark from 06.00 p.m. - 06.00 a.m.).
Food and drinking water (from water bottles) were available ad libitum.
in life data: start 2002-01-29 until: 2002-03-19
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test substance was weighed out and thoroughly mixed with a small amount of food. Then corresponding amounts of food were added to this premix in order to obtain the desired concentration, and mixing was carried out for 10 minutes in a laboratory mixer. The mixtures were prepared weekly and kept cold (+4°C). The food was changed twice a week.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the test substance in the diet was demonstrated over a period of up to 4 days at room temperature and up to 4 days in the refrigerator. As the mixtures were stored no longer than this time period, the stability was guaranteed.
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 500 ppm
- Remarks:
- corresponding to 142.3 mg/kg bw/day and 153.3 mg/kg bw/day in males and females, respectively.
- Dose / conc.:
- 5 000 ppm
- Remarks:
- corresponding to 478.5 mg/kg bw/day and 529.9 mg/kg bw/day in males and females, respectively.
- Dose / conc.:
- 15 000 ppm
- Remarks:
- corresponding to 1462.9 mg/kg bw/day and 1552.1 mg/kg bw/day in males and females, respectively.
- No. of animals per sex per dose:
- Control group: 10 animals per sex
1500 and 5000 ppm groups: 5 animals per sex
15000 ppm group: 10 animal per sex - Control animals:
- yes, plain diet
- Details on study design:
- In a test study the test item was administered to groups of 3 male and 3 female Wistar rats at dose levels of 1000, 5000 and 15000 ppm for 2 weeks. Food consumption, water consumption, body weight and clinical signs were recorded. As no substance-related findings or signs of toxicity were observed, the following dose levels were selected for the present study: 15000 ppm as high concentration; this concentration results in an test substance intake of at least 1,000 mg/kg body weight/day which is the highest dose to be tested for non-toxic test substances in a 'limit test'; 5000 ppm: as mid dose and 1500 ppm: as low dose.
The oral route was selected since this was proven to be suitable for the detection of a toxicological hazard. - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD EFFICIENCY:
- Food consumption was determined weekly over a period of 4 days and calculated as mean food consumption in grams per animal and day
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 29
- Anaesthetic used for blood collection: No
- Animals fasted: Yes
- How many animals: all
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 29
- Animals fasted: Yes
- How many animals: all
URINALYSIS: Yes
- Time schedule for collection of urine: day 29
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: end of the treatment period
- Dose groups that were examined: all animals
- Battery of functions tested: home cage observations, sensory activity, motor activity, open field - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Statistics of clinical pathology
Means and standard deviations of each test group were calculated for several parameters.
Further statistical analyses were performed for:
(1) CIinical pathology parameters, except differential blood count: Non-parametric one-way analysis using KRUSKAL-WALLIS test (two-sided). If the resulting p-value was equal or less than 0.05, a pairwise comparison of each dose group with the control group was performed using Wilcoxon-test (two-sided) for the equal medians.
(2) Urinalysis, except volume, colour, turbidity and specific gravity.
Statistics of pathology
Non-parametric one-way analysis using KRUSKAL-WALLIS test (two-sided). If the resulting p-value was equal or less than 0.05, a pairwise comparison of each dose group with the control group was performed using the WILCOXON test for the hyphothesis of equal medians.
For the animals of the recovery group: Pairwise comparison of each dose group with the control group was performed using the WILCOXON test (two-sided) for the hypothesis of equal medians.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- yellow discoloration of faeces
- Mortality:
- no mortality observed
- Description (incidence):
- yellow discoloration of faeces
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Details on results:
- In summary:
15,000 ppm (1462.9 mg/kg bw/d in males; 1552.1 mg/kg bw/d in females): no substance-related toxic effects were obtained in the main as well as recovery groups.
5,000 ppm (478.5 mg/kg bw/d in males; 529.9 mg/kg bw/d in females): no substance-related toxic effects.
1,500 ppm (142.3 mg/kg bw/d in males; 153.3 mg/kg bw/d in females): no substance-related toxic effects.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Corresponds to the highest dose tested. No adverse effects occured.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 462.9 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Corresponds to the highest dose tested. No adverse effects occured.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 552.1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Corresponds to the highest dose tested. No adverse effects occured.
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
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.