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Diss Factsheets
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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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-08-25 to 2016-04-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 421 (July 1995)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OPPTS 870.3550 (July 2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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
- Source and lot/batch No.of test material: 002-122106
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- other: Wistar rats, strain Crl:WI(Han)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 321.1 g – 355.1 g (males); 196.3 g – 222.2 g (females)
- Fasting period before study: No
- Housing: During the study period, the rats were housed individually in Polycarbonate cages type III supplied by Becker & Co., Castrop-Rauxel, Germany (floor area of about 800 cm²) and TECHNIPLAST, Hohenpeißenberg, Germany, with the following exceptions: During overnight matings, male and female mating partners were housed together in Polycarbonate cages type III. Pregnant animals and their litters were housed together until PND 4.
- Diet: Ground Kliba maintenance diet mouse/rat “GLP” meal, supplied by Provimi Kliba SA, Kaiseraugst, Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: About 5 days
ENVIRONMENTAL CONDITIONS:
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Air change: 15 times per hour
- Photoperiod:12 hours light (from 6.00 h to 18.00 h) and 12 hours darkness (from 18.00 h to 6.00 h)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The required quantity of test substance was weighed in a beaker depending on the test group and thoroughly mixed with a small amount of food (Ground Kliba maintenance diet mouse/rat). Then further amounts of food were added to this premix and thoroughly mixed. Afterwards, further amounts of food, depending on the dose group, were added to this premix in order to obtain the desired concentrations. Mixing of this final mix was carried out for about 3 minutes in a laboratory mixer. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical verifications of the stability of the test substance in the diet for a period of 35 days at room temperature were carried out before the study was initiated with a comparable batch. Samples of the test substance preparations were sent to the analytical laboratory once during the study period for verification of the concentration. The samples, which were taken for the concentration control analysis at the beginning of the administration period, were also used to verify the homogeneity.
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: Maximum of 2 weeks
- Proof of pregnancy: Proof of pregnancy: Detection of mating was confirmed by sperm in vaginal smear. The day on which sperm were detected was denoted "GD 0" and the following day "GD 1". - Duration of treatment / exposure:
- 30 days (males);
50 – 56 days (females) - Frequency of treatment:
- Daily
- Duration of test:
- 30 days (males);
50 – 56 days (females)
- No. of animals per sex per dose:
- 10
- Control animals:
- other: yes, treated with diet only
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least once daily
- Cage side observations included morbidity, pertinent behavioral changes and signs of overt toxicity.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Once a week. The follwoing exceptions are notable for the female animals: During the mating period the parental females were weighed on the day of positive evidence of sperm (GD 0) and on GD 7, 14, and 20. Females with litter were weighed on the day after parturition (PND 1) and on PND 4.
FOOD CONSUMPTION AND COMPOUND INTAKE:
- 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 - Ovaries and uterine content:
- not examined
- Fetal examinations:
- not examined
- Statistics:
- Statistical analyses were performed with the following statistical tests:
Food consumption, body weight and body change, gestation days: DUNNET test (two-sided)
Male and female mating indices, male and female fertility indices, females mated, females delivering, gestation index, females with liveborn pups, females with all stillborn pups: FISHER'S EXACT test (one-sided)
Mating days until day 0 pc, % postimplantation loss, pups stillborn, % perinatal loss, implantation sites, pups delivered, pups liveborn, live pups day x, viability index: WILCOXON test (one-sided) with BONFERRONI-HOLM
% live male day x, % live female day x: WILCOXON test (two-sided)
Weight parameters (pathology): KRUSKAL-WALLIS test (two-sided) and WILCOXON-test (two-sided) - Indices:
- Viability index (%), Sex ratio (%), stillborn and liveborn pups (%), postimplantation loss (%), perinatal loss (%)
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects: yes
Details on maternal toxic effects:
Test following substance-related adverse effects/findings were noted at 812 mg/kg bw/d (12000 ppm):
- Decreased food consumption in the females during premating days 0-7 and 0-13 (about 14% and 9% below control, respectively), during the entire gestation period (up to 15% below control) and during the entire lactation period (about 31% below control)
- Decreased body weights in the females on GD 20 (about 7% below control) and during the entire lactation period (up to 14% below control)
- Decreased body weight change in the females during PND 1-4 (about 67% below control)
- Reduced terminal body weight in females (94%)
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 261 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 261 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Test following substance-related adverse effects/findings were noted at 812 mg/kg bw/d (12000 ppm):
- Decreased pup body weights on PND 4 (about 25% below control)
- Decreased pup body weight gain on PND 1 - 4 (about 49% below control)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 812 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Decreased pup body weights on PND 4 and decreased pup body weight gain on PND 1 - 4
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
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.
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