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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-01 to 1984-06-05
- 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 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Ambiguity in the identification of the batch; purity of the test material was not indicated.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
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
- Species:
- rat
- Strain:
- other: Alderley Park specific pathogen free (SPF) albino rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 -7 weeks
- Weight at study initiation: 144 - 182 g (males), 124 - 155 g (females)
- Fasting period before study: 16 - 20 hours
- Housing: 5 per cage, in stainless steel cages, 370 x 320 x 200 mm; floor and back: 12 mm square mesh, door: Makrolon (polycarbonate);
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21°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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- suspension
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: nominal 100, 200, 500 mg/mL, analytically determined 97, 202, 499 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight, except males at 1000 mg/kg, which received 11 mL/kg.
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): not reported
- Purity: not reported
MAXIMUM DOSE VOLUME APPLIED: 11 mL/kg
- Rationale for the selection of the starting dose: Results from preliminary study with small number of animals (not further specified) - Doses:
- nominal: 1000 (males only), 2000, 5000 mg/kg
analytically determined: 1067 (dosing volume adjusted to low analytical concentration), 2020, 4990 mg/kg - No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations on day 1: twice (30-90 min and 4-6 h after dosing); once daily thereafter; weighing: day -1 (before fasting and application), days 1, 3, 6 (or 4, in lowest dose group), 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None
Results and discussion
- Preliminary study:
- No details reported; used to set three nominal doses for main study (1000, 2000, 5000 mg/kg body weight)
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 990 mg/kg bw
- Based on:
- test mat.
- Remarks:
- analytical determination
- Remarks on result:
- other: Maximum mortality 2/5 at 2020 mg/kg bw, lower mortality (1/5) at 4990 mg/kg bw, no meaningful statistical calculation possible
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 4 990 mg/kg bw
- Based on:
- test mat.
- Remarks:
- analytical determination
- Remarks on result:
- other: Maximum mortality 2/5 at 4990 mg/kg bw, no meaningful statistical calculation possible
- Mortality:
- All deaths occurred within 48 hours after application.
Males: 0/5 at 1067 mg/kg bw, 2/5 at 2020 mg/kg bw, 1/5 at 4990 mg/kg bw
Females: 0/5 at 2020 mg/kg bw, 2/5 at 4990 mg/kg bw - Clinical signs:
- other: Most common signs of toxicity: decreased activity, piloerection, dehydration and signs of urinary incontinence, stains (partially bloody) around the nose, upward curvature of the spine. In the lowest dose group (1067 mg/kg bw, males only), symptoms start
- Gross pathology:
- No macroscopic abnormalities were observed.
- Other findings:
- None reported
Any other information on results incl. tables
Table 1: Cumulative mortality
Sex | Day | 1067 | 2020 | 4990 |
mg/kg bw | mg/kg bw | mg/kg bw | ||
Males | 1 | 0/5 | 2/5 | 0/5 |
2 | 0/5 | 2/5 | 1/5 | |
15 | 0/5 | 2/5 | 1/5 | |
Females | 1 | not tested | 0/5 | 0/5 |
2 | not tested | 0/5 | 2/5 | |
15 | not tested | 0/5 | 2/5 |
Table 2: Mean body weight and standard deviation (SD)
Sex | Dose | Day: | BW gain | |||||||
mg/kg bw | -1 | 1 | 3 | 4 | 6 | 8 | 15 | survivors | ||
M | 1067 | Mean bw | 154.2 | 133.8 | 162.4 | 171.2 | 205.2 | 265.0 | 110.0 | |
+/- SD | 13.9 | 13.6 | 10.7 | 10.6 | 11.8 | 14.0 | ||||
M | 2020 | Mean bw | 169.4 | 148.4 | 174.3 | 201.7 | 217.7 | 274.3 | 97.0 | |
+/- SD | 11.4 | 9.4 | 12.5 | 11.1 | 15.0 | 16.2 | ||||
M | 4990 | Mean bw | 167.0 | 145.4 | 162.0 | 189.0 | 200.0 | 264.8 | 100.0 | |
+/- SD | 9.5 | 10.6 | 9.4 | 5.6 | 5.7 | 8.7 | ||||
F | 2020 | Mean bw | 138.0 | 119.0 | 141.2 | 157.6 | 164.8 | 196.6 | 59.0 | |
+/- SD | 6.0 | 5.6 | 6.8 | 9.0 | 7.5 | 9.2 | ||||
F | 4990 | Mean bw | 136.2 | 117.4 | 128.3 | 150.0 | 156.0 | 188.7 | 57.0 | |
+/- SD | 11.6 | 11.5 | 6.4 | 11.1 | 8.7 | 11.8 |
Table 3: Clinical observations: Number of animals affected and days of occurrence
Clinical observations Males | group 03 | group 01 | group 02 | |||
mg/kg bw | 1067 | 2020 | 4990 | |||
Males: number of animals | 5 | 5 | 5 | |||
animals | days | animals | days | animals | days | |
activity decreased | 1 | 2 | 1 | 4 | 1-4 | |
found dead | 0 | 2 | 1 | 1 | 2 | |
killed termination | 5 | 15 | 3 | 15 | 4 | 15 |
signs of diarrhoea | 1 | 3 | 0 | 3 | 0 | |
splayed gait | 1 | 1 | 0 | 1 | 1 | |
reduced stability | 3 | 1 | 2 | 1 | 3 | 1-2 |
tip toe gait | 0 | 1 | 1 | 1 | 1 | |
chromodacryorrhea | 0 | 0 | 2 | 2-3 | ||
abdominal tone decreased | 0 | 1 | 1 | 2 | 1 | |
dehydrated | 2 | 1 | 3 | 1-2 | 4 | 1-4 |
piloerection | 1 | 1 | 0 | 3 | 1-5 | |
salivation | 0 | 0 | 3 | 1 | ||
sides pinched in | 3 | 1 | 2 | 1 | 3 | 1-2 |
signs of salivation | 2 | 1 | 2 | 1-2 | 2 | 1-3 |
stained around mouth | 0 | 0 | 1 | 1-2 | ||
stains around nose | 2 | 1 | 3 | 1-4 | 5 | 1-4 |
signs of urinary incontinence | 2 | 2-4 | 3 | 2-5 | 4 | 1-5 |
ungroomed | 0 | 1 | 1 | 2 | 2-4 | |
urinary incontinence | 0 | 3 | 1 | 2 | 1 | |
upward curvature of spine | 4 | 1-2 | 3 | 1-3 | 4 | 1-3 |
reduced righting reflex | 0 | 1 | 1 | 2 | 1 | |
breathing depth increased | 0 | 0 | 1 | 1 | ||
breathing rate reduced | 0 | 0 | 1 | 1 |
Clinical observations Females | group 01 | group 02 | ||||
mg/kg bw | 1067 | 2020 | 4990 | |||
Females: number of animals | 0 | 5 | 5 | |||
animals | days | animals | days | animals | days | |
activity decreased | 3 | 1 | 4 | 1-3 | ||
bizarre behaviour | 0 | 1 | 1 | |||
tremors | 0 | 1 | 1 | |||
found dead | 0 | 2 | 2 | |||
killed termination | 5 | 15 | 3 | 15 | ||
diarrhoea | 1 | 1 | 0 | |||
reduced stability | 3 | 1 | 3 | 1 | ||
chromodacryorrhea | 0 | 1 | 2 | |||
abdominal tone decreased | 0 | 3 | 1 | |||
dehydrated | 4 | 1-4 | 5 | 1-3 | ||
hypothermia | 0 | 2 | 1 | |||
piloerection | 2 | 1-2 | 5 | 1-11 | ||
salivation | 1 | 1 | 0 | |||
sides pinched in | 3 | 1 | 4 | 1 | ||
signs of salivation | 4 | 1-2 | 5 | 1-2 | ||
stains around nose | 3 | 1-2 | 5 | 1-4 | ||
signs of urinary incontinence | 3 | 2-4 | 3 | 1-7 | ||
ungroomed | 1 | 3-4 | 3 | 1-4 | ||
urinary incontinence | 2 | 1 | 3 | 1-2 | ||
hair loss (general) | 0 | 1 | 6-15 | |||
upward curvature of spine | 3 | 1 | 5 | 1-3 | ||
reduced righting reflex | 1 | 1 | 3 | 1 | ||
breathing depth increased | 1 | 1 | 1 | 1 | ||
breathing rate reduced | 0 | 2 | 1 | |||
breathing depth reduced | 1 | 1 | 1 | 1 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test substance was estimated to be greater than 4990 mg/kg bw to male and female rats. Confidence limits could not be calculated. The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.
- Executive summary:
The acute oral toxicity of the test material (a powder) was assessed according to a method similar to OECD 401 in groups of five male and five female rats, at doses of 1067 (males only), 2020, and 4990 mg/kg body weight (bw). The test substance was applied as a suspension in corn oil by oral gavage. Mortalities, signs of toxicity, and body weight development were recorded during 15 days; survivors were examined by necropsy for macroscopic abnormalities.
Mortalities in all dose groups up to 4990 mg/kg bw were less than 50% (1/5 or 2/5 animals), so that a statistical calculation of the LD50 (by interpolation) could not be performed. The most common clinical symptoms were decreased activity, piloerection, dehydration, signs of urinary incontinence, stains around the nose, and upward curvature of the spine. They subsided within 3 - 7 days, except for one high-dose male. Body weights initially decreased (due to fasting), but reached their initial values around day 4 - 6 after treatment and increased normally thereafter. No macroscopical abnormalities were detected.
The author estimates an acute oral LD 50 of > 4990 mg/kg bw to male and female rats.
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