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EC number: 617-441-5 | CAS number: 83121-18-0
- 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
- Study period:
- 1986-08-14 to 1986-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- 1982
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 617-441-5
- Cas Number:
- 83121-18-0
- Molecular formula:
- C14 H6 Cl2 F4 N2 O2
- IUPAC Name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: commercial rabbit breeding organisation (H. Fortkamp, 4540 Lengerich, Germany).
- Age at study initiation: 14 to 17 weeks
- Weight at study initiation: range of 3.0 to 3.7 kg
- Fasting period before study: no
- Housing: housed individually in metal cages with perforated bottoms
- Diet: ad libitum, pelleted form (Rabbit Diet, DEUKA Deutsche Kraftfutterwerke GmbH, Germany)
- Water: ad libitum
- Acclimation period: at least one week prior to start of mating
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test article was prepared as a suspension in the vehicle at least once weekly. During dosing, the suspensions were kept homogeneous with a magnetic stirrer. The formulations were stored in a refrigerator at approximately 4 to 8 °C.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test item can be suspended in CMC.
- Concentration in vehicle: 100 mg/L
- Amount of vehicle: 10 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analysis of three samples of a 100 g/L suspension of test item in CMC show that the suspension was homogeneous and accurately prepared. The test article is stable in the suspension for at least three days at room temperature.
- Details on mating procedure:
- - Impregnation procedure: natural mating
- Does that successfully completed coitus received an intravenous injection of 50 I.U. of a luteinizing hormone to ensure ovulation.
The day of mating was designated as day 0 of gestation. - Duration of treatment / exposure:
- from day 6 to 18 post-coitum
- Frequency of treatment:
- daily
- Duration of test:
- 13 days
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 22 (treatment group), 16 (ctr group)
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: All female rabbits were examined at Ieast twice daily for signs of ill-health, toxicity, and behavioural change. All changes were recorded. Daily mortality checks were also performed.
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: The body weight of each inseminated female rabbit was recorded on days 0, 6 to 18, 24, and 28 post-coitum and evaluated for days 0, 6, 12, 18, 24, and 28 post-coitum.
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- The food consumption was determined weekly.
WATER CONSUMPTION AND COMPOUND INTAKE: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on day 28 post coitum
- Organs examined: ovaries, uteri
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Blood sampling:
- not performed
- Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [all per litter]
- Skeletal examinations: Yes: [all per litter]
- Head examinations: Yes: [half per litter]
- Anogenital distance of all live rodent pups: No - Statistics:
- For body weight, body weight gain, food consumption, Iitter weight, and fetal weights (overall, males, females), the student's t-test was performed. Number of corpora lutea, number of implantations, number of fetuses, post-implantation loss, pre-impIantation loss, and proportion of male fetuses (sex ratio) were statistically analyzed using the Mann-Whitney U-test.
- Indices:
- see table 1
- Historical control data:
- yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment-related clinical signs were observed in the treated animals
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One control animal died on day 16-post coitum. Necropsy showed pulmonary findings. One animal in the treated group aborted on day 18-post coitum and was sacrified. Autopsy revealed pulmonary findings. Another animal in this group aborted on day 26-post coitum and was sacrificed. The occurrence of those 2 abortions was not considered to be treatment related.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Group mean body weight gain of the treated animals was comparable with the control group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Reduced water consumption was occasionally observed in control and compound treated animals. This finding was considered to be not treatment-reIated.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At necropsy on day 28 p.c., occasional minor findings (mainly grossly granulated cut surface of the liver) were detected at higher incidence in the dose group than in the control group. The finding might be treatment-reIated. No further changes were observed at necropsy. One female in the treatment group showed 100 % intra-uterine death at necropsy. It was not possible to determine whether or not this effect was resulting from an effect of the treatment.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One animal in group 2 (1000 mg/kg bw/day) aborted on day 18 p.c. and was killed. Autopsy revealed pulmonary findings. One further female in group 2 (1000 mg/kg bw/day) aborted on day 26 p.c. and was killed.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- There was no effect of treatment on implantations.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- The mean number of total intra-uterine death was lower in group 2 (1000 mg/kg bw/day) than in the control group.
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- The mean number of fetuses per dam was higher in the treated group than in the control group.
- Changes in pregnancy duration:
- not examined
- Changes in number of pregnant:
- not examined
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- maternal
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: highest dose tested
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The mean fetal weight in the treated group was comparable with the control group.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- The mean number of foetuses per doe was higher in group 2 (1000 mg/kg) than
in the control group. - Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not examined
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In one fetus of the treated group, an aplasia of the tail was noted.
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Two control fetus showed fused ribs.
Two fetuses of the treated group showed skeletal malformations as fused or fissured ribs.
Due to the nature and incidence of these effects, their occurrence was considered to be incidental.
The incidence of skeletal variations in the treated animals was comparable with the controls. - Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
Overall developmental toxicity
- Key result
- Developmental 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.
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