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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 1999 (study initiation date)
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Acute Dermal 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.3-2.5 kg
- Diet: 5 ounces of pelleted rodent feed per day.
- Water: Municipal water was provided ad libitum.
- Acclimation period: Animals were acclimated to the laboratory environment for at least two weeks prior to study start.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3 °C
- Humidity (%):40 - 60 %
- Air changes (per hr): approximately 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: 1 May 1999 To: 31 August 1999
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 0.5 % methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Trunk of each rabbit.
- Site preparation: Clipped free of fur the day prior to application of the test material.
- % coverage: Approximately 10 % of the surface area of the rabbits.
- Type of wrap if used: The site was covered with a gauze/cotton patch (approximately 10 x 14 cm), held in place by an elastic jacket.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was wiped thoroughly with a water-moistened, soft disposable towel and dried with a soft disposable towel.
- Time after start of exposure: 24 hours.
VEHICLE
- Amount applied: The test material was moistened with 12.0 mL of 0.5 % methylcellulose. - Duration of exposure:
- 24 hours
- 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:
A detailed clinical observation (DCO) was conducted for all rabbits prior to test material administration for comparison with the observations recorded throughout the study. Animals were observed a minimum of 2 times, one of which was a DCO, on the day of treatment. A DCO was done each day (including weekends and holidays) during the study. Hand-held and open-field observations included a careful physical examination.
For scored DCO’s, only observations other than normal were recorded. Observations were dictionary based, and the dictionary contained most of the common physical and neurologic abnormalities seen in toxicity studies. Since not all potential observations were contained in the dictionary, free-field descriptions also were allowed.
The rabbits were weighed pre-study, the day of treatment (day 1) and on test days 2, 8, and 15.
- Necropsy of survivors performed: Yes
At study termination, all animals were euthanized with Beuthanasia solution. 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, including the treatment site 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 occured during the study.
- Clinical signs:
- other: There were no clinical signs of systemic toxicity. All rabbits had reddened and thickened skin at the dermal test site on day 2. In addition, one male had perineal faecal soiling on day 2 only. In all animals, the reddening and thickening of the skin reso
- Gross pathology:
- There were no treatment-related gross pathologic observations.
Any other information on results incl. tables
Table 1: Individual Body Weights
Dose (mg/kg) |
Animal Sex |
Animal No. |
Day of Test |
||||
-4 |
1 |
2 |
8 |
15 |
|||
5000 |
Male |
3921 |
2368.0 |
2396.0 |
2305.6 |
2593.8 |
2621.1 |
3922 |
2381.9 |
2402.7 |
2344.5 |
2665.3 |
2693.7 |
||
3923 |
2354.8 |
2386.6 |
2341.8 |
2540.9 |
2542.6 |
||
3924 |
2441.7 |
2507.3# |
2406.6 |
2760.5 |
2737.1 |
||
3925 |
2354.1 |
2401.1 |
2285.8 |
2621.9 |
2586.1 |
||
Mean |
2380.1 |
2418.7 |
2336.9 |
2636.5 |
2636.1 |
||
SD |
36.3 |
49.9 |
46.2 |
82.7 |
79.0 |
||
Female |
3926 |
2409.0 |
2336.1 |
2415.3 |
2516.7 |
2625.0 |
|
3927 |
2257.0 |
2255.6 |
2078.7 |
2392.8 |
2449.1 |
||
3928 |
2406.0 |
2400.9 |
2302.4 |
2575.0 |
2605.6 |
||
3929 |
2382.4 |
2381.7 |
2270.2 |
2670.1 |
2542.9 |
||
3930 |
2333.1 |
2334.3 |
2284.8 |
2481.0 |
2508.1 |
||
Mean |
2357.5 |
2341.7 |
2270.3 |
2527.1 |
2546.1 |
||
SD |
63.9 |
56.1 |
121.4 |
103.7 |
71.8 |
# statistical outliers inculded
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 dermal LD50 of the test material for male and female New Zealand White rabbits was greater than 5000 mg/kg.
- Executive summary:
The acute dermal toxicity of the test material was determined in a study performed under GLP conditions and in line with the standardised guidelines OECD 402, EPA OPPTS 870.1200, EU Method B.3 and Japan MAFF Acute Dermal Toxicity Study, 1985.
Five male and five female New Zealand White rabbits received a single 24 hour exposure to 5000 mg/kg body weight applied to shaved intact skin. The test material was moistened with 12.0 mL of 0.5 % methylcellulose. Parameters evaluated included body weights, detailed clinical observations, and gross pathologic evaluations.
All rabbits survived the 5000 mg/kg dose level. There were no clinical signs of systemic toxicity. All rabbits had reddened and thickened skin at the dermal test site on day 2. In addition, one male had perineal faecal soiling on day 2 only. In all animals, the reddening and thickening of the skin resolved by day 4. All rabbits lost body weight on days 1 or 2, and then surpassed their pre-study weights by study termination. There were no treatment-related gross pathologic observations.
Under the conditions of the test, the acute dermal LD50 of the test material for male and female New Zealand White rabbits was greater than 5000 mg/kg.
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