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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Ambiguity in the identification of the batch; purity of the test material not indicated; inconsistent duration of exposure (contact period): 24 or 27 hours.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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
- 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: 277 - 312 g (males), 200 - 235 g (females)
- Fasting period before study: 16 - 20 hours
- Housing: individual, 2 per cage (separated by a solid metal partition, 1 animal per compartment) 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
- Type of coverage:
- occlusive
- Vehicle:
- sorbitan derivative
- Remarks:
- 0.3 mL of a 0.5% polysorbate 80 solution
- Details on dermal exposure:
- TEST SITE
- Hair removal, by clipping, 100 x 50 mm on dorso-lumbar area
- Area of exposure: patch size approx. 75 x 50 mm
- % coverage: not reported
- Type of wrap if used: aluminium foil patch , kept in place using adhesive impermeable tape (approx. size 250 x 75 mm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleansed using swabs of absorbent cotton wool soaked in clean warm water, then dried with tissue paper
- Time after start of exposure: 24 or 27 hours; the report is inconsistent, it states "kept in contact for 24 hours" and a "27-hour contact period"
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight (bw)
- Concentration (if solution): not reported; solid test substance weighed out onto an aluminium patch, then moistened with 0.3 mL of 5% polysorbate 80
- Constant volume or concentration used: yes (constant volume of 5% polysorbate 80)
- For solids, paste formed: yes
VEHICLE
- Amount applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): 0.5%
- Lot/batch no. (if required): not reported
- Purity: not reported - Duration of exposure:
- 24 or 27 hours; the report is inconsistent, it states "test substance kept in contact with the skins for 24 hours" and a "27-hour contact period" in two subsequent paragraphs
- Doses:
- 2000 mg/kg body weight (bw)
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations on day 1: once (between 1 and 4 h after dosing); once daily thereafter; weighing: day 1 (before application), days 3, 6, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none (limit test)
Results and discussion
- Preliminary study:
- No details reported; used to set the nominal dose for the limit test main study (2000 mg/kg body weight)
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality
- Mortality:
- None
- Clinical signs:
- other: Signs of systemic toxicity (mostly on day 2 only): diarrhoea, stains around the nose, signs of urinary incontinence, and upward curvature of the spine. The stains persisted in one female until day 5. Signs of skin irritation: - scab formation (at edge of
- Gross pathology:
- No macroscopic abnormalities were observed.
- Other findings:
- None reported.
Any other information on results incl. tables
Table 1: Mean body weight and standard deviation (SD)
Sex | Dose | Day: | BW gain | |||||
mg/kg bw | 1 | 3 | 6 | 8 | 15 | |||
M | 2000 | Mean bw | 293.6 | 279.6 | 292.6 | 309.6 | 331.4 | 37 |
+/- SD | 12.4 | 12.3 | 14.6 | 15.3 | 15.6 | |||
F | 2000 | Mean bw | 213.6 | 209.4 | 215.4 | 222.6 | 234.8 | 21 |
+/- SD | 13.4 | 7.9 | 12.2 | 14.2 | 11.6 |
Table 2: Clinical observations: Number of animals affected and days of occurrence
Clinical observation | Males | Females | ||
mg/kg bw | 2000 | 2000 | ||
animals | days | animals | days | |
number of animals | 5 | 5 | ||
killed at termination | 5 | 15 | 5 | 15 |
signs of diarrhoea | 1 | 2 | 1 | 2 |
stains around nose | 1 | 2 | 3 | 2-5 |
signs of urinary incontinence | 1 | 2 | 3 | 2 |
urinary incontinence | 0 | 1 | 2 | |
upward curvature of spine | 1 | 2 | 0 | |
desquamation | 0 | 3 | 4-7 | |
skin eruptions ? | 2 | 2-7 | 0 | |
scab: edge of applic. area | 0 | 2 | 6-15 | |
scabs: small scattered | 1 | 6-11 | 1 | 4-12 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 of the test substance was estimated to be greater than 2000 mg/kg bw to male and female rats. Confidence limits could not be calculated (limit test). The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.
- Executive summary:
The acute dermal toxicity of the test material (a powder) was assessed according to OECD 402 in a limit test with five male and five female rats, at a dose of 2000 mg/kg body weight. The test substance was moistened with 0.3 mL of 0.5% polysorbate 80 and applied dermally as a paste, then covered with an occlusive dressing (aluminium foil). Mortalities, signs of toxicity, and body weight development were recorded during 15 days; survivors were examined by necropsy for macroscopic abnormalities.
Mortalities were not observed at this dose. Signs of systemic toxicity were mostly seen on day 2: diarrhea, stains around the nose, signs of urinary incontinence, and upward curvature of the spine. Skin irritation was observed between day 4 and 15 (scab formation in 1/5 male and 3/5 females, slight desquamation in 3/5 females). Body weights initially decreased, but reached their initial values around day 8 after treatment and increased thereafter. No macroscopical abnormalities were detected.
The author estimates an acute dermal LD50 of > 2000 mg/kg bw to both sexes.
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