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EC number: 691-719-4 | CAS number: 1072957-71-1
- 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:
- from 2011-05-05 to 2011-05-25 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- from May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- from August 1998
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-[11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undeca-2,4,6-trien-3-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
- EC Number:
- 691-719-4
- Cas Number:
- 1072957-71-1
- Molecular formula:
- C18H15Cl2F2N3O
- IUPAC Name:
- N-[11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undeca-2,4,6-trien-3-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
- Details on test material:
- - Physical state: Beige powder
- Stability under test conditions: not reported
- Reanalysis date of the lot/batch: End of February 2013
- Storage condition of test material: At room temperature (20 ± 5 °C), light protected
- Safety Precautions: Routine hygienic procedures (gloves, goggles, face mask)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White Rabbit, SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 14 weeks (male), 14 – 15 weeks (females)
- Weight at study initiation: 2612 g (male), 2886 g – 3066 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. A piece of wood and a haystick were provided for environmental enrichment.
- Diet (e.g. ad libitum): Pelleted Teklad Global Rabbit diet 2031C ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum.
- Acclimation period: 5-6 days, under laboratory conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Single administration into the eye
- Observation period (in vivo):
- 10 days
Viability/mortality and clinical signs: assessed daily from acclimatization to termination of the test.
Eye reactions: assessed at approximately 1, 24, 48 and 72 hours as well as 7 and 10 days after treatment.
Body weights: recorded at acclimatization, on the day of treatment and on the last day of observation.
Fluorescein staining: employed at least 24 hours prior to instillation of the test item and 24, 48 and 72 hours as well as 7 days post dose after the standard observations had been made - Number of animals or in vitro replicates:
- 1 male, 2 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Numerical evaluation (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49). Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281 289 was used to classify the ocular irritancy potential of the test material.
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp. To assess for the presence of corneal damage, instillation of a 0.5% fluorescein solution was performed directly onto the cornea of both eyes and assessment was made with a hand slit lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: conjunctivae redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: conjuntivae redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: conjunctivae redness
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: corneal opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hours after application
- Score:
- 2.67
- Max. score:
- 110
- Remarks on result:
- other: Scoring according to Kay and Calandra
- Irritant / corrosive response data:
- - No corrosion was observed at any of the measuring intervals.
- Slight reddening of the sclera was observed in two animals 1 hour after treatment.
- Test item remnants were observed in two animals 1 hour after treatment.
- Positive corneal fluorescence was observed in all animals 24 hours after treatment and persisted until 72 hours after treatment. Corneal fluorescence was negative 7 days after treatment. - Other effects:
- - No staining of the treated eyes by the test item was noted.
- No clinical signs were observed.
- The test item did not induce irreversible damage to the rabbit eye.
Any other information on results incl. tables
Eye Irritation Scores
Animal number |
Sex |
Evaluation Interval |
Corneal Opacity |
Area of Corneal Opacity |
Iris light reflex |
Conjunctivae |
Sclera |
Test Item Remnants |
|
Redness |
Chemosis |
||||||||
61 |
M |
1 hour |
0 |
0 |
0 |
2 |
0 |
1 |
1 |
62 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
63 |
F |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
|
61 |
M |
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
62 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
63 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
61 |
M |
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
62 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
63 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
61 |
M |
72 hours |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
62 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
63 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
61 |
M |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
62 |
F |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
63 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
61 |
M |
10 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
62 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
63 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the Kay and Calandra classification criteria, the test item is considered to be "moderately irritating" to the rabbit eye (maximum average score = 2.67; not all scores were zero at the 72 hour reading). The study is regarded to be adequate and reliable.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD TG 405 in a valid GLP study. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7 and 10 days after test item instillation.
The instillation of the test item into the eye resulted in slight to moderate reddening of the conjunctivae in all animals and slight reddening of the sclera in two animals. Test item remnants were observed in two animals. These eye reactions were reversible and were no longer evident 7 days (two animals) or 10 days (one animal) after treatment, the end of the observation period for all animals. Positive corneal fluorescence was observed in all animals 24 hours after treatment and persisted until 72 hours after treatment. No abnormal findings were observed in the iris of any animal at any of the observations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was noted. Furthermore, no clinical signs were observed. The test item did not induce irreversible damage to the rabbit eye. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00 for reddening and 0.00 for chemosis for all animals. Based on the Kay and Calandra interpretation, the mean of the cumulative scores for eye irritation was 2.67 at 1 hour, 2.00 at 24, 48 and 72 hours, 0.67 after 7 days and 0.00 after 10 days.
Based upon the Kay and Calandra classification criteria, the test item is considered to be “moderately irritating” to the rabbit eye (maximum average score = 2.67; not all scores were zero at the 72 hour reading).
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