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EC number: 939-383-2 | CAS number: -
- 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
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- May 12, 1981
- Deviations:
- yes
- Remarks:
- A functional test battery was not included.
- GLP compliance:
- yes
- Remarks:
- CIBA-GEIGY Limited Short/Long-term Toxicology 4332 Stein / Switzerland
- Limit test:
- no
Test material
- Reference substance name:
- 3-[4-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonamide, reaction products with aqueous organic chromium(III) complex sodium salt, then laked with acidified C10-14-tert-alkyl(linear and branched) amines
- EC Number:
- 939-383-2
- Molecular formula:
- UVCB substance
- IUPAC Name:
- 3-[4-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonamide, reaction products with aqueous organic chromium(III) complex sodium salt, then laked with acidified C10-14-tert-alkyl(linear and branched) amines
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- other: albino: Tif: RAIf (SPF), hybrids of RII/1 x RII/2
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Production, CIBA-GEIGY Limited, 4332 Stein / Switzerland
- Age at study initiation: approx. 5 weeks at delivery
- Weight at study initiation: 175.0 - 198.2 g in males and 142.0 - 169.9 g in females
- Fasting period before study: no
- Housing: 5/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 16 - 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The substance was weighed on a calibrated Mettler balance. The pulverized food was then homogeneously mixed with the appropriate amounts. Diet was stored deep-frozen in a separate area until use.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 ppm
- Dose / conc.:
- 600 ppm
- Dose / conc.:
- 2 400 ppm
- Dose / conc.:
- 12 000 ppm
- Dose / conc.:
- 3.7 mg/kg bw (total dose)
- Remarks:
- average calculated intake males based on food intake
- Dose / conc.:
- 50.7 mg/kg bw (total dose)
- Remarks:
- average calculated intake males based on food intake
- Dose / conc.:
- 200.1 mg/kg bw (total dose)
- Remarks:
- average calculated intake males based on food intake
- Dose / conc.:
- 1 075 mg/kg bw (total dose)
- Remarks:
- average calculated intake males based on food intake
- Dose / conc.:
- 4.1 mg/kg bw (total dose)
- Remarks:
- average calculated intake females based on food intake
- Dose / conc.:
- 57 mg/kg bw (total dose)
- Remarks:
- average calculated intake females based on food intake
- Dose / conc.:
- 204 mg/kg bw (total dose)
- Remarks:
- average calculated intake females based on food intake
- Dose / conc.:
- 1 141 mg/kg bw (total dose)
- Remarks:
- average calculated intake females based on food intake
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels were based on the results of the following previously conducted study: Test no. 904252: Acute oral toxicity in the rat Test no. 904287: 14-days range finding study in the rat
- Post-exposure recovery period in satellite groups: 4 weeks
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: All animals were checked daily (a.m. and p.m. on working days, a.m. on weekends and holidays), in order to record mortalities, and to allow dead or moribund animals to be submitted to necropsy as soon as possible.
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
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: Yes
WATER CONSUMPTION: Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: all animals of experimental groups I and II at the end of the treatment period, and on all animals of experimental group II at the end of the recovery period
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: Yes
- How many animals: all
- Parameters checked: Erythrocyte Count, Hemoglobin,Hematocrit, Mean corpuscular volume, Reticulocytes, Leucocyte Count, Differential Leucocyte Count, Thrombocyte Count, Prothrombin Time, Methemoglobin
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: all animals of experimental groups I and II at the end of the treatment period, and on all animals of experimental group II at the end of the recovery period
- Animals fasted: Yes
- How many animals: all
- Parameters checked: Glucose, Urea, Creatinine, Total bilirubin, Total protein, Albumin, Globulins, A/G Ratio, Cholesterol, Triglycerides, Sodium, Potassium, Calcium, Chloride, Phosphorus inorganic, Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Gamma-glutamyl
transpeptidase
URINALYSIS:Yes
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
weights were determined for:
brain
liver
kidneys
adrenals
o v a r i e s / t e s t es
HISTOPATHOLOGY: Yes
mesenteric lymph node
stomach
small intestine
large intestine
spleen
mesenteric lymph node
heart
liver
stomach
sraall intestine
large intestine
kidney, both
adrenal gland, both
any organ with gross lesions - Statistics:
- For each time point and parameter an univariate statistical analysis was performed. Nonparametric methods were applied, to allow for non normal as well as normal data distribution. Each treated group was compared to the control group either by Lepage's or by Wilcoxon's two-sample test and tested for increasing or decreasing trends from control up to the respective dose group by Jonckheere's test for ordered alternatives. The Lepage test is a combination of Wilcoxon and Ansari-Bradley statistics , i. e. a combined test for location and dispersion. The Lepage test has a good power against the more general alternative that the distributions differ not only in location but also in distribution. The Jonckheere testt is sensitive to monotone dose-related effects. Two-sided asymptotic p-values are reported in the "statistics" tables.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 12 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: There were slight effects on liver and kidney weight which may have been incidental.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
Red discoloration of feces due to the red substance was noted in groups 3, 4 and 5 (600, 2400 and 12000 ppm).
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.
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