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EC number: 939-946-2 | CAS number: -
- 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:
- 2011-11-08 to 2011-12-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study conducted to OECD Guideline 425
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- reaction mass of (3R,5R)-3-chloro-5-(trichloromethyl)cyclopentene and (3S,5S)-3-chloro-5-(trichloromethyl)cyclopentene and (3R,4R)-3-chloro-4-(trichloromethyl)cyclopentene and (3S,4S)-3-chloro-4-(trichloromethyl)cyclopentene
- EC Number:
- 939-946-2
- Molecular formula:
- C6H6Cl4
- IUPAC Name:
- reaction mass of (3R,5R)-3-chloro-5-(trichloromethyl)cyclopentene and (3S,5S)-3-chloro-5-(trichloromethyl)cyclopentene and (3R,4R)-3-chloro-4-(trichloromethyl)cyclopentene and (3S,4S)-3-chloro-4-(trichloromethyl)cyclopentene
- Test material form:
- other: Dark Brown Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:(WI)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions.
Justification of strain: Recognized by international guidelines as a recommended test system.
Number of animals: 1 animal/step.
Sex: Female rats.
Age when treated: Young adult rats, 8 - 11 weeks old.
Body weight (at dosing): The weight variation in animals involved in the study was not exceed ± 20 % of the mean weight.
Target Body weight range: 210 – 229 g (at dosing).
Randomization: Selected by hand at time of delivery.
Acclimatization time: At least 5 days under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study
Husbandry
Animal health: Only healthy animals were used for the test. The health status was certified by the veterinarian.
Housing: Individual caging.
Cage type: Type II. polypropylene/polycarbonate.
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 22±3 °C.
Relative humidity: 30 – 70 %.
Ventilation: 15-20 air exchanges/hour.
Enrichment: Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities. The temperature and relative humidity were recorded twice daily during the study and the acclimation period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- The animals received a single oral (gavage) administration of the test item followed by a 14 day observation period. For approximately 16 hours before treatment the animals were fasted, but had free access to water. Animals were weighed before dosing and the food was returned approximately 3 hours after treatment.
Single animals were dosed sequentially following an interval of approximately 48 hours. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Treatment of an animal at the next dose was performed when no significant clinical signs were noted in the previous animal.
The main test was completed having met one of the stopping criteria. Once the stopping criteria was attained, the estimated LD50 was calculated from the animal outcomes at test termination - Doses:
- 175-2000 mg/kg bw
- No. of animals per sex per dose:
- 1
- Control animals:
- no
- Details on study design:
- An acute oral toxicity (up and down procedure) study was conducted with 6 animals. The starting dose was 550 mg/kg bw. Animals were treated with a single oral (gavage) dose of the substance at a dose level of 175, 550 or 2000 mg/kg bw.
- Statistics:
- The type, severity and duration of clinical observations were recorded. Body weight and body weight changes were summarized in tabular form. Necropsy findings were described and summarized in tabular form.
Data was evaluated using the Acute Oral Toxicity (OECD Test Guidelines 425) Statistical Programme (AOT 425 Stat Pgm).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 123.9 - < 3 930
- Remarks on result:
- other: Approximate 95% confidence interval is 123.9 to 3930 mg/kg body weight.
- Mortality:
- Mortality was observed in all animals receiving a single dose of the substance at 2000 mg/kg bw (2/2) and 550 mg/kg bw (1/3). No mortality was observed following treatment at 175 mg/kg bw (0/1).
- Clinical signs:
- other: Treatment with the substance at the dose level of 2000 mg/kg bw caused decreased activity (2/2), hunched back (2/2), piloerection (2/2), increased salivation (2/2) and lateral position (1/2). In addition orange coloured urine was observed in all animals.
- Gross pathology:
- A single oral gavage of the substance to the CRL:(WI) female rat led to the death of 3 animals dosed at 550 or 2000 mg/kg bw. The surviving animals were subjected to the necropsy on Day 14 and no macroscopic observations were noted.
Any other information on results incl. tables
Animal Number | Dosage (mg/kg bw) | Dose Volume (ml/animal) | Viability/Mortality |
9687 | 550 | 2.2 | Survived |
9688 | 2000 | 2.1 | Died |
9689 | 550 | 2.3 | Died |
9690 | 175 | 2.2 | Survived |
9691 | 550 | 2.3 | Survived |
9692 | 2000 | 2.2 | Died |
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Approximate 95% confidence interval is 123.9 to 3930 mg/kg body weight Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dose (LD50) of the substance was calculated to be 550 mg/kg bw in female CRL:(WI) rats. Approximate 95% confidence interval is 123.9 to 3930 mg/kg body weight.
The study is considered to be relevant, reliable, adequate for risk assessment, and adequate for classification purposes. - Executive summary:
An acute oral toxicity (up and down procedure) study was conducted with 6 animals (female CRL: WI rat). The starting dose was 550 mg/kg bw. Animals were treated with a single oral (gavage) dose of the substance at a dose level of 175, 550 or 2000 mg/kg bw followed by a 14 day observation period. The animals were fasted overnight prior to treatment and food was returned approximately 3 hours after dosing. Surviving animals were observed individually after dosing at 30 minutes, 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured on Day -1 (prior to removal of food), Day 0 (prior to administration) and weekly thereafter. All surviving animals were examined macroscopically at the end of the study. Moreover, the animals found dead were examined macroscopically and body weight was recorded at necropsy.
Results:
2000 mg/kg body weight (two animals) Mortality was observed in all animals at 2000 mg/kg bw (2/2). Treatment with the substance at the dose level of 2000 mg/kg bw caused decreased activity, hunched back, piloerection and increased salivation in all animals and lateral position in one. In addition orange coloured urine was observed in all animals. Dark/red discoloration of the non-collapsed lungs was found in 2/2 found dead rats at necropsy. In addition, many dark red foci in the thymus was found in one animal.
550 mg/kg body weight (three animals) Mortality was observed following treatment at 550 mg/kg bw (1/3). Clinical signs of toxicity were observed in two animals. These included decreased activity, hunched back , increased salivation and piloerection. Additionally, piloerection was noted in two rats dosed at 550 mg/kg bw. One animal showed no clinical signs of toxicity and was symptom free throughout the observation period. Dark/red discoloration of the non-collapsed lungs and enlarged adrenals was found in the found dead rat at necropsy. There were no macroscopic findings noted in surviving animals dosed at 550 mg/kg bw.
175 mg/kg body weight (one animal) No adverse clinical signs were observed following treatment at 175 mg/kg bw. There were no macroscopic findings noted in animal dosed at 175 mg/kg bw. Body weight measurements of the surviving animals during the study showed no indication of a treatment-related effect.
Conclusion
Under the conditions of this study, the acute oral median lethal dose (LD50) of the substance was calculated to be 550 mg/kg bw in female CRL:(WI) rats. Approximate 95% confidence interval is 123.9 to 3930 mg/kg body weight.
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