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EC number: 218-500-4 | CAS number: 2164-17-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 to 28 July 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study The experiments were done according to the EPA FIFRA, Subdivision F, §81-5 (1984) = EEC B.4 (1992). USA TSCA, Section HG ‘Primary Dermal Irritation’
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fluometuron
- EC Number:
- 218-500-4
- EC Name:
- Fluometuron
- Cas Number:
- 2164-17-2
- Molecular formula:
- C10H11F3N2O
- IUPAC Name:
- fluometuron
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: fluometuron, 1,1-dimethyl-3-[3-(trifluoromethyl)phenyl]urea
- Physical state: white powder
- Analytical purity: 96.8% (w/w)
- Batch number: batch no. 1223
- Date of arrival: 12 July 1989
- Storage conditions: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - group of six New Zealand white rabbits (five males/ one female)
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- weight: 2.42 - 3.38 kg
- age:twelve to sixteen weeks old
- free access to mains drinking water and food
- animal room temperature: 17 - 22°C
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- distilled
- Controls:
- no
- Amount / concentration applied:
- singl dermal doses: 0.5 g, semi-occluded application of test material, moistened with distilled water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Approximately one hour following the removal of the patches, and 24, 48, and 72 hours later
- Number of animals:
- six
- Details on study design:
- PROCEDURE
Approximately twenty-four hours prior to the commencement of the test, each group of six rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of a 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approximate size patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period of four hours.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Approximately one hour following the removal of the patches, and 24, 48, and 72 hours later, the test sites were examined for evidence of primary irritation and score according the scale i.e. Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin Texas, "The Appraisal of the safety of the Chemicals in Foods, Drugs and Cosmetics".
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24 h
- Score:
- 0.2
- Max. score:
- 0.2
- Reversibility:
- no data
- Remarks on result:
- other: primary irritation index: 0.08
- Irritant / corrosive response data:
- A very slight erythema was noted in one animal at one and 24 hours after patch removal. No other adverse affects were noted see Table 7.3.1.-01
Any other information on results incl. tables
Table 7.3.1.-01: Individual and mean skin irritation scores
Animal No.
|
Erythema and Eschar (E) Oedema (O) |
Hours |
|||
1 |
24 |
48 |
72 |
||
140 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
144 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
148 |
E O |
1 0 |
1 0 |
0 0 |
0 0 |
161 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
174 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
180 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
Mean score |
E O |
- - |
0.2 0 |
0 0 |
0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information in accordance with the provisions of regulation 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- In this study the mean skin scores for 24 to 72 hours after removal of the test article were < 2, therefore, in accordance with the provisions of regulation 1272/2008, Annex I, 3.2 , it is proposed fluometuron is not classified as a skin irritant.
- Executive summary:
1. A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The study was designed to comply with the requirements of the U.S.A. Environmental Protection Agency (EPA).
2. A single 4-hour. semi-occluded application of the test material to the skin of six rabbits produced very slight erythema at one treated skin site, No other adverse skin responses were noted
3. The test material produced a primary irritation index of 0.08 and was classified as a mild irritant to rabbit skin.
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