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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 July to 04 August 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, §81-4 (1984) = EEC B.5 (1992). USA TSCA, Section HG ‘Primary Eye 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 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - group of six New Zealand white rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- weight: 2.54 - 3.09 kg
- age:twelve to sixteen weeks old
- free access to mains drinking water and food
- animal room temperature: 16 - 22°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1ml of the test material fluometuron, purity 96.8%
- Duration of treatment / exposure:
- 1, 24, 48, 72 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- six
- Details on study design:
- Six New Zealand White rabbits each received 0.1ml of the test material (as measured by gently compacting the required volume into an adapted syringe) by a singular ocular instillation without irrigation to the lower everted lid of one eye of each animal. The upper and lower eyelids were held together for about one second immediatly after application, to prevent loss of the test material, and then released.
The left eye remained untreated and was used for control purposes.
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treeatment. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: maximum group mean score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0 - 4
- Max. score:
- 4
- Remarks on result:
- other: mean irritancy score for the 24 and 72 hours was 0-0.3
- Irritation parameter:
- overall irritation score
- Remarks:
- mean irritancy score
- Basis:
- mean
- Time point:
- other: 24,72 hours
- Score:
- >= 0 - <= 3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: no adverse effects were noted at the 72-hour observation and the study was terminated
- Irritant / corrosive response data:
- No adverse corneal or iridial effects were noted during the study period.
Minimal conjunctival irritation was noted in all rabbits one hour after treatment and in two treated eyes after 24 hours. No other adverse conjunctival effects were noted see Table 7.3.2.-01 - Other effects:
- no other effects were recognized
Any other information on results incl. tables
Table 7.3.2.-01: Individual and mean eye irritation scores
Animal No. |
Region of eye |
Hours |
|||
|
|
1 |
24 |
48 |
72 |
189 |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 1 1 |
0 0
0 1 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
207 |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 1 1 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
168 |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
146 |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
206 |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 1 1 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
182 |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 0 0 |
0 0
0 1 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
Mean score |
Cornea – degree of opacity area of opacity
Iris Conjunctiva – redness chemosis discharge |
0 0
0 1 0.5 0.5 |
0 0
0 0.3 0 0 |
0 0
0 0 0 0 |
0 0
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information According to the provisions of regulation 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- In this study the mean irritancy score for the 24 and 72 hours was 0-0.3. Therefore, fluometuron was only minimally and transiently irritating to the rabbit eye.In accordance with the provisions of regulation 1272/2008, Annex I, 3.3, it is proposed classification is not required. It is proposed fluometuron technical it is not classified as an eye irritant.
- Executive summary:
1. A study was performed to assess the irritancy potential of the test material to the eye 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 application of the test material to the non-irrigated eye of six rabbits produced minimal conjunctival irritation in all treated eyes. No other adverse effects were noted.
3. The test material produced a maximum group mean score of 4.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
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