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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / 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
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:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- July 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OPPTS 870.3550
- Version / remarks:
- 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)
- Sex:
- male/female
- 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 (post natal day) 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. - 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".
GD = gestation day. - 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.
- Duration of treatment / exposure:
- 30 days (males);
50 – 56 days (females) - Frequency of treatment:
- Daily
- Details on study schedule:
- - Age at mating of the mated animals in the study: 11 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 200 ppm
- Remarks:
- corresponding to 85 mg/kg bw/day
- Dose / conc.:
- 3 600 ppm
- Remarks:
- corresponding to 261 mg/kg bw/day
- Dose / conc.:
- 12 000 ppm
- Remarks:
- corresponding to 812 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Control animals:
- other: yes, treated with diet only
- Details on study design:
- - Dose selection rationale: Range-finder study
Examinations
- Parental animals: Observations and 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 - Oestrous cyclicity (parental animals):
- Not examined.
- Sperm parameters (parental animals):
- Parameters examined in P male parental generations:
testes weight, epididymides weight - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring:
Number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities.
GROSS EXAMINATION OF DEAD PUPS:
yes. All pups were examined externally and eviscerated; their orangs were assessed macroscopically. All pups without notable findings or abnormalities were discarded after their macroscopic evaluation. Animals with notable findings or abnormalities were evaluated on a case-by-case basis, depending on the type of finding. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals after 30 days
- Maternal animals: All surviving animals 50 and 56 days
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS
Certain tissues (see "Any other information on materials and methods") were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed on postnatal day (PND) 4.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including visceral findings. - 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) - Reproductive indices:
- Mating index (%), fertility index (%), gestation index (%), live birth index (%), postimplantation loss (%)
- Offspring viability indices:
- Viability index (%), sex ratio (%), stillborn and liveborn pups (%), postimplantation loss (%), perinatal loss (%)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- 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
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
There were no test substance-related or spontaneous mortalities in any of the groups. All male and female F0 generation parental animals of test groups 1 to 3 (1200, 3600 and 12000 ppm) had dark red discolored feces throughout the entire study period.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Food consumption of the high-dose F0 females was significantly below the concurrent control values during premating days 0-7 and 0-13 (about 14% and 9% less, respectively), during the entire gestation period (maximum of 15% less) and during the entire lactation period (about 31% less).
Further, a trend to a lower mean body weight gain was observed for the high-dose F0 females, and the difference to the control became significant on GD 20 (7.4% below control). During lactation period, mean body weights were significantly lower in female animals of test group 3 (14.3% below control on PND 4). Test group 3 females (12000 ppm) had a lower body weight gain during gestation (overall 18% below control) despite the difference was not statistically significant to the control. A significantly lower body weight gain was observed in female animals of test groups 2 and 3 (3600 and 12000 ppm) from PND 1 to PND 4 (about 46% and 67%, respectively). As the body weights in test group 2 were not different to control this single change in weight gain is not considered toxicologically relevant. The lower weight gain in test group 3 on the other hand was consistent with decreased body weights, therefore it is considered treatment-related and adverse.
GROSS PATHOLOGY (PARENTAL ANIMALS)
The glandular stomach, jejunum and colon of almost all parental male and female animals of test groups 1 to 3 (1200, 3600 and 12000 ppm) showed red discoloration of the contents. This change was consistent with the red color of the test substance and was regarded as treatment-related but not adverse. All other findings occurred either individually or were biologically equally distributed over control and treatment groups. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
HISTOPATHOLOGY (PARENTAL ANIMALS)
All findings occurred either individually or were biologically equally distributed over control and treatment groups. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic toxicity)
- Effect level:
- 812 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Corresponds to 12000 ppm
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (fertility and reproductive performance)
- Effect level:
- 812 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Corresponds to 12000 ppm
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic toxicity)
- Effect level:
- 261 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Corresponds to 3600 ppm; reduced food consumption and impaired body weight development in females at 812 mg/kg bw/d (12000 ppm)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
The viability index indicating pup mortality during lactation (PND 0-4) was 100%, 99.3%, 100% and 93.8% in test groups 0-3, respectively.
BODY WEIGHT (OFFSPRING)
Mean body weights of the high-dose (12000 ppm) male and female pups were significantly below the concurrent control values at PND 4 (average 24.6% below control). In addition, mean body weight change of the high-dose male and female pups was significantly below the concurrent control values from PND 1 to PND 4 (average 49%). The mean body weights and body weight change of the mid- and low-dose male and female pups were comparable to the concurrent control group throughout the entire study period. Four male and four female runts were recorded for test group 3 (12000 ppm) and one female runt was seen in the test group 2 (3600 ppm).
GROSS PATHOLOGY (OFFSPRING)
A few pups showed spontaneous findings at gross necropsy, such as dilated ureter, dilated renal pelvis, post mortem autolysis, empty stomach, and red discolored testis (left). These findings occurred without any relation to dosing and/or can be found in the historical control data at comparable or even higher incidences. Thus, all these findings were not considered to be associated to the test substance.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (developmental toxicity)
- Generation:
- F1
- Effect level:
- 261 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Corresponds to 3600 ppm; Based on lower pup weights at 812 mg/kg bw/d (12000 ppm): Average pup weights 24.6 % below control; average weight gain 49 % below control
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
Analysis
The various analyses
- demonstrated the stability of the test substance preparations over a period of 35 days at room temperature
- confirmed the homogeneous distribution of the test substance in the diet
- verified correct concentrations of the
test substance in the diet preparations
Absolute and relative weights
Absolute weights
When compared to control group 0 (set to 100%), the mean absolute
terminal body weight of the parental females was significantly decreased
as follows:
Absolut weights |
Females |
||
Test group (ppm) |
1 (1200) |
1 (3600) |
3 (12000) |
Terminal body weight |
102 % |
100% |
94 %** |
*: p<= 0.05, **: p <= 0.01
The findings in test group 3 were statistically significant.
All other mean absolute weight parameters did not show significant differences when compared to the control group 0.
Relative organ weights
All mean relative weight parameters did not show significant
differences when compared to the control group 0.
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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