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EC number: 217-586-0 | CAS number: 1895-39-2
- 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:
- From 20-07-2022 to 15-08-2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium chlorodifluoroacetate
- EC Number:
- 217-586-0
- EC Name:
- Sodium chlorodifluoroacetate
- Cas Number:
- 1895-39-2
- Molecular formula:
- C2HClF2O2.Na
- IUPAC Name:
- sodium chloro(difluoro)acetate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 12 Females (nulliparous and non-pregnant)
- Age: 9-10 weeks old.
- Housing: Three animals were housed in standard polycarbonate cage (size: L 430 x B 280 x H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized corn
cob was provided as bedding material.
- Diet: Altromin Maintenance Diet for rats and mice manufactured by Altromin Spezialfutter GmbH & Co. KGAd libitum.
- Water: Ad libitum. Deep bore-well water passed through reverse osmosis unit was provided in plastic water bottles with stainless steel sipper tubes.
- Acclimatization: Healthy young adult animals used for Step-I, Step-I confirmation, Step-II and Step- II confirmation were acclimatized for five, seven, nine and twelve days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt.
ENVIRONMENTAL CONDITIONS
- Temperature: 19,8ºC to 22,9ºC
- Humidity: 45 to 65%
- Air changes: 12 to 15 air changes/hour
- Light hours: 12 hours light and 12 hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water. The test item is soluble in distilled water as evidenced by the in-house solubility/suspendibility test.
- Details on oral exposure:
DOSAGE PREPARATION: The required quantity of test item was weighed, grind well using mortar and pestle by adding little volume of vehicle and transferred into the measuring cylinder. Again a small quantity of vehicle was added to mortar, mixed well and transferred into the measuring cylinder. The rinsing procedure was repeated to ensure complete transfer of the test item formulation into a measuring cylinder. Finally, the volume was added to the required mark to get a desired concentration.
DOSAGE ADMINSTRATION: by gavage, in a single dose- Doses:
- Step 1: 300 mg/kg bw
Step 2: 2000 mg/kg bw - No. of animals per sex per dose:
- Step 1 (300 mg/kg bw): 3 animal
Step 1 confirmation (300 mg/kg bw): 3 animals.
Step 2 (2000 mg/kg bw): 3 animal
Step 2 confirmation (2000 mg/kg bw): 3 animals. - Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period.
- Necropsy of survivors performed: yes.
- Clinical signs including body weight: included changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other:
- Body weight:
- lower than 10% body weight loss
- Remarks:
- No adverse changes were observed in body weight and percent change in body weight with respect to day 1.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Any other information on results incl. tables
Table 1. Individual animal body weight (g) and percent change in body weight with respect to day 1.
Study Steps & Dose (mg/kg body weight) | Animal No. | Sex | Volume Administered (mL) | Body Weight (g) on Day | Percent Change in Body Weight with Respect to Day | |||
1 | 8 | 15 | 1 to 8 | 1 to 15 | ||||
Step-I & 300 | Rh2248 | F | 1.7 | 173.01 | 187.22 | 204.85 | 8.21 | 18.40 |
Rh2249 | F | 1.8 | 175.36 | 189.46 | 208.54 | 8.04 | 18.92 | |
Rh2250 | F | 1.7 | 170.67 | 184.46 | 208.54 | 7.89 | 17.10 | |
Mean | 173.01 | 186.94 | 204.42 | 8.05 | 18.14 | |||
SD | 2.35 | 2.68 | 4.36 | 0.16 | 0.94 | |||
n | 3 | 3 | 3 | 3 | 3 | |||
Step-I Confrimation & 300 | Rh2251 | F | 1.7 | 172.47 | 187.11 | 204.51 | 8.49 | 18.58 |
Rh2252 | F | 1.7 | 171.08 | 186.24 | 201.88 | 8.86 | 18.00 | |
Rh2253 | F | 1.7 | 164.37 | 179.53 | 198.18 | 9.22 | 20.61 | |
Mean | 169.31 | 184.29 | 201.52 | 8.86 | 19.06 | |||
SD | 4.33 | 4.15 | 3.18 | 0.37 | 1.37 | |||
n | 3 | 3 | 3 | 3 | 3 | |||
Step-II & 2000 | Rh2254 | F | 1.8 | 178.61 | 194.66 | 208.31 | 8.99 | 16.63 |
Rh2255 | F | 1.8 | 181.91 | 196.59 | 211.58 | 8.07 | 16.31 | |
Rh2256 | F | 1.8 | 175.55 | 188.05 | 202.11 | 7.12 | 15.13 | |
Mean | 178.69 | 193.10 | 207.33 | 8.06 | 16.02 | |||
SD | 3.18 | 4.48 | 4.81 | 0.93 | 0.79 | |||
n | 3 | 3 | 3 | 3 | 3 | |||
Step-II Confirmation & 2000 | Rh2257 | F | 1.7 | 170.55 | 187.82 | 202.45 | 10.13 | 18.70 |
Rh2258 | F | 1.8 | 176.97 | 192.65 | 208.92 | 8.86 | 18.05 | |
Rh2259 | F | 1.8 | 180.99 | 197.21 | 210.88 | 8.96 | 16.51 | |
Mean | 176.17 | 192.56 | 207.42 | 9.32 | 17.76 | |||
SD | 5.27 | 4.70 | 4.41 | 0.70 | 1.12 | |||
n | 3 | 3 | 3 | 3 | 3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is 5000 mg/ kg body weight by oral route in the rat.
- Executive summary:
Acute Oral Toxicity - Acute Toxic Class Method” and classified as “Category 5 or unclassified (2000 < ATE ≤ 5000 mg/kg body weight)”
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