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EC number: 601-779-5 | CAS number: 121451-02-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 August 1999 to 24 August 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Acute Oral Toxicity Study, 1985.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 601-779-5
- Cas Number:
- 121451-02-3
- Molecular formula:
- C17H7Cl2F9N2O3
- IUPAC Name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid
- Details on test material:
- - Substance type: White solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 106-165 g
- Fasting period before study: rats were fasted the night prior to treatment.
- Diet: pelleted rodent diet, ad libitum.
- Water: municipal water, ad libitum.
- Acclimation period: at least two weeks prior to study start.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 12-15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark photocycle, lights on at 6:00 a.m. and off at 6:00 p.m.
IN-LIFE DATES: From: 14 June 1999 To: 24 August 1999
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 % - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Five per sex per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Detailed clinical observations were performed each day during the study.
Hand-held and open-field observations included a careful physical examination were performed during the study.
Each animal was weighed prestudy, the day of treatment, and on days 2, 8, and 15.
- Necropsy of survivors performed: yes
All rats submitted alive for necropsy were anesthetised by inhalation of methoxyflurane vapours and euthanised by decapitation after exposure and clamping of the trachea. A complete necropsy was conducted on all animals by a veterinary pathologist assisted by a team of trained individuals. The eyes were examined in situ using a moistened glass microscope slide applied to the corneal surface. Following inspection of the externum and body orifices, the nasal, cranial, oral, thoracic, and abdominal cavities were opened and the visceral organs were examined both in situ and following dissection. - Statistics:
- Means and standard deviations were calculated for body weights. The data were evaluated for statistical outliers by a sequential test (Grubbs, 1969), however, outliers were not routinely excluded from statistical analysis.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: One male and one female had perineal faecal soiling on test days 1 or 2, and one male had perineal faecal soiling on test day 15. All other animals were clinically normal throughout the study.
- Gross pathology:
- There were no treatment related gross pathologic observations for any animal.
Any other information on results incl. tables
Table 1: Individual Body Weights
Dose (mg/kg) |
Animal Sex |
Animal No. |
Day of Test |
||||
-1 |
1 |
2 |
8 |
15 |
|||
5000 |
Male |
3901 |
172.6 |
160.5 |
179.1 |
202.2 |
225.6 |
3902 |
175.9 |
164.5 |
181.8 |
207.4 |
231.9 |
||
3903 |
170.5 |
157.5 |
175.3 |
198.0 |
219.9 |
||
3904 |
176.4 |
164.2 |
182.7 |
205.0 |
232.4 |
||
3905 |
167.4 |
154.1 |
172.4 |
196.3 |
216.8 |
||
Mean |
172.6 |
160.2 |
178.3 |
201.8 |
225.3 |
||
SD |
3.8 |
4.4 |
4.4 |
4.6 |
7.0 |
||
Female |
3906 |
120.7# |
111.2# |
123.1 |
140.9 |
151.9 |
|
3907 |
115.1 |
106.3 |
120.5 |
132.1 |
145.0 |
||
3908 |
116.3 |
106.0 |
121.2 |
135.0 |
146.3 |
||
3909 |
115.9 |
105.9 |
120.7 |
134.2 |
144.3 |
||
3910 |
115.4 |
105.8 |
120.6 |
133.2 |
142.6 |
||
Mean |
116.7 |
107.0 |
121.2 |
135.1 |
146.0 |
||
SD |
2.3 |
2.3 |
1.1 |
3.4 |
3.5 |
# statistical outlier included
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the acute oral LD50 of the test material in male and female Fischer 344 rats was greater than 5000 mg/kg.
- Executive summary:
The acute toxicity of the test material was determined in an acute oral toxicity test performed under GLP conditions and in accordance with the standardised guidelines OECD 401, EPA OPPTS 870.1100, EU Method B.1 and Japan MAFF Acute Oral Toxicity Study.
Five male and five female Fischer 344 rats received 5000 mg/kg of the test material as a 50 % mixture in 0.5 % methylcellulose by single dose oral gavage. Parameters evaluated during the two-week observation period included body weights and detailed clinical observations. All animals were examined for gross pathologic changes.
All animals survived for the duration of the study. One male and one female had perineal faecal soiling on test days 1 or 2, and one male had perineal faecal soiling on test day 15. All other animals were clinically normal throughout the study. Rats had a transient body weight loss on day 1, which was associated with the overnight fast prior to treatment, and then gained body weight for the remainder of the study. There were no treatment-related gross pathologic observations for any animal.
Under the conditions of the test, the acute oral LD50 of the test material in male and female Fischer 344 rats was greater than 5000 mg/kg.
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