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EC number: 614-283-9 | CAS number: 68127-59-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-01 to 1984-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period limited to 7 days, in spite of slight conjunctival redness + discharge on day 7; animal room temperature slightly low (16°C); purity of test material not reported.
- GLP compliance:
- yes
Test material
- Reference substance name:
- reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid
- EC Number:
- 614-283-9
- Cas Number:
- 68127-59-3
- Molecular formula:
- C9H10ClF3O2
- IUPAC Name:
- reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid
- Details on test material:
- - Physical state: crystalline powder
- Colour: white
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.76 - 3.61 kg
- Housing: individually in satinised aluminium sheet cages, 605 x 490 x 455 mm; floor: perforated aluminium sheet, door: Makrolon (polycarbonate)
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 16°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): approx. 100 mg solid test substance / test eye (left eye)
- Application into the conjunctival sac of the left eye
- Concentration (if solution): not applicable
VEHICLE
- none - Duration of treatment / exposure:
- - Lids of treated eye gently held together for 1-2 seconds
- 3 / 9 animals: irrigation of treated eye after 20 - 30 seconds - Observation period (in vivo):
- 1 - 2 hours, 1, 2, 3, 4, and 7 days after application
- Number of animals or in vitro replicates:
- 9 male rabbits, thereof 3 with eye irrigation shortly after application
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals: washing with 200 mL clean lukewarm water
- Time after start of exposure: 20 - 30 seconds after application of test substance
- No washing in 6 animals
SCORING SYSTEM:
- Draize scale for scoring ocular lesions:
Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics, Association of Food and Drug Officials of the US, 46.
- Interpretation / classification of numerical scores:
Kay JH & Calandra JC (1962) J. Soc. Cosmet. Chem. 13: 6 (modified, as documented in appendix 6 of the study)
TOOL USED TO ASSESS SCORE: none reported
INITIAL PAIN REACTION:
- Assessed immediately after application
- Scale 0 - 5 points, depending on observed reactions, according to descriptions shown in appendix 4 of report
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- iris score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation; reported as redness
- Irritation parameter:
- chemosis score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- iris score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation; reported as redness
- Irritation parameter:
- chemosis score
- Basis:
- other: animal 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- iris score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation; reported as redness
- Irritation parameter:
- chemosis score
- Basis:
- other: animal 17
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: without irrigation
- Irritant / corrosive response data:
- Slight iritis and slight corneal opacity were observed in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.
- Other effects:
- Initial pain reaction: practically none to moderate (classes 1-3 on a 0-5 scale)
Slight mucoid discharge and slight Harderian discharge on day 3 in one animal each
Any other information on results incl. tables
One animal in the non-irrigated group became sick and had to be killed on day 6 after the application; it still showed conjunctival discharge. Another one (with irrigated eye) was found dead on day 3, with slight redness, chemosis, and discharge. The author does not attribute the deaths to effects of the test material.
Table 1: Data for individual animals without irrigation:
Animal | Sex | Elapsed | Cornea | Iris | Conjunctiva | Total | ||||||
no | time | Opacity | Area | Score | Score | Redness | Chemosis | Discharge | Score | Score | ||
(A) | (B) | (AxBx5) | (C) | (Cx5) | (D) | (E) | (F) | (D+E+F)x2 | ||||
15 | M | 1.4 hrs | 0 | 0 | 0 | 1 | 5 | 2 | 2 | 3 | 14 | 19 |
1 day | 1 | 1 | 5 | 0 | 0 | 2 | 2 | 1 | 10 | 15 | ||
2 days | 1 | 1 | 5 | 0 | 0 | 2 | 1 | 1 | 8 | 13 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
16 | M | 1.5 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 14 | 14 |
1 day | 1 | 1 | 5 | 0 | 0 | 2 | 2 | 2 | 12 | 17 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | ||
17 | M | 1.4 hrs | 0 | 0 | 0 | 1 | 5 | 2 | 2 | 3 | 14 | 19 |
1 day | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 10 | 10 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
6 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | ||
6 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | ||
18 | M | 1.4 hrs | 1 | 1 | 5 | 1 | 5 | 2 | 2 | 3 | 14 | 24 |
1 day | 1 | 1 | 5 | 0 | 0 | 2 | 1 | 2 | 10 | 15 | ||
2 days | 1 | 1 | 5 | 0 | 0 | 2 | 1 | 2 | 10 | 15 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
19 | M | 1.4 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 14 | 14 |
1 day | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 12 | 12 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
20 | M | 1.4 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 14 | 14 |
1 day | 1 | 1 | 5 | 0 | 0 | 2 | 2 | 1 | 10 | 15 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 4 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 |
Table 2: Data for individual animals with irrigation:
Animal | Sex | Elapsed | Cornea | Iris | Conjunctiva | Total | ||||||
no | time | Opacity | Area | Score | Score | Redness | Chemosis | Discharge | Score | Score | ||
(A) | (B) | (AxBx5) | (C) | (Cx5) | (D) | (E) | (F) | (D+E+F)x2 | ||||
12 | M | 1.3 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 |
1 day | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
1 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
13 | M | 1.5 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 12 | 12 |
1 day | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
3 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
4 days | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
7 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
14 | M | 1.4 hrs | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 12 | 12 |
1 day | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 | ||
2 days | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 6 | 6 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The irritant potential of the test substance to the rabbit eye was found to be moderate (class 5 on a 1-8 scale) without irrigation, and mild (class 4) after irrigation. The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.
- Executive summary:
The acute eye irritation potential of the test material (a powder) was assessed according a method similar to OECD 405 in nine male New Zealand White rabbits. The test substance (0.1 g) was applied directly into the conjunctival sac of the left eye of the animals; the right eye served as control. The eyes of three rabbits were irrigated with 200 mL of lukewarm water 20-30 seconds after the application. The ocular reactions were assessed at the following time points: 1-2 hours, 1, 2, 3, 4, and 7 days post application, according to the Draize scale.
Practically none to moderate initial pain was observed immediately after the application of the test substance.
Slight iritis and slight corneal opacity were recorded in 3/6 animals without irrigation; both effects were reversible (within 1 and 3 days after application, respectively), and both did not occur after irrigation. Conjunctivitis included moderate redness and chemosis, as well as severe discharge, which improved markedly after a maximum between 2 hours and 1 day after exposure, but were not fully reversible during the observation period of seven days in the non-irrigated eyes. Even after irrigation, conjunctivitis persisted until day four. The author classifies the test substance as a moderate irritant (class 5 on a 1-8 scale) when applied without subsequent irrigation, and as a mild irritant (class 4 of 8) after irrigation.
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