Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 903-945-5 | 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
Endpoint summary
Administrative data
Description of key information
- The reaction mass of CDFA/TFA is considered fatal by the oral route based on the available data on chlorodifluoroacetic acid.
- The reaction mass of CDFA/TFA being highly corrosive no studies on acute dermal and inhalation toxicity were performed and no classification is required.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 03 jan 1990 to 23 aug 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, OECD 401 compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo (69592 L'Arbresle, France)
- Age at study initiation: 5 to 7 weeks old
- Weight at study initiation: 127 to 173 g
- Housing: 5 par sex and per group, in polycarbonte cages, type MI (365x225x180 mm)
- Diet (e.g. ad libitum): ad libitum, rat-mice pellets (U.A.R, formule A.04 - U.A.R Villemoison, 91360 Epinay/Orge, France)
- Water (e.g. ad libitum): softened and filtered water (0.6µm), ad libitum
- Acclimation period: 10 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: not indicated - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.066 mL/kg
- Doses:
- 0, 26, 56, 75 and 101 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: the day before treatment, just before administration, Day 8 and Day 15, or just after death.
Clinical signs and mortality: 1/4 hour, 1 hour, 2 hours and 4 hours after gavage, then daily up to day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Clinical signs: breathing, piloerection, central nervous system, tremor, salivation . . .
In a preliminary test, the product was tested at the following doses: 62.7, 125.5, 250.9 and 500.3 mg/kg. There was 100% of mortality at 125.5, 250.9 and 500.3 mg/kg and 75% at 62.7 mg/kg. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 26 - < 56.6 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Lethality was caused by local corrosive effects.
- Mortality:
- 10% at 26 mg/kg, 80% at 56.6 mg/kg, 90% at 75 mg/kg and 100% at 101 mg/kg.
- Clinical signs:
- other: At 26 mg/kg: no clinical signs observed. At 56.6 mg/kg: roaring breathing, piloerection, ataxia. Nomore clinical signs after 7 or 8 days in the survivals. there 3/5 deaths in males and 5/5 deaths in females. At 75 mg/kg: ataxia in all animals, with roarin
- Gross pathology:
- Oesophagus perforation, stomach ulcer (at the highest dose), congestive areas in lungs.
- Interpretation of results:
- Toxicity Category II
- Conclusions:
- Chlorodifluoroacetic acid is fatal if swallowed according to CLP 1272/2008.
- Executive summary:
In a GLP study, Chlorodifluoroacetic acid was tested to evaluate the acute toxicity following a single oral adminitration at doses from 0, 26, 56.6, 75 and 101 mg/kg bw undiluted.
There were 0, 10 80, 90 and 100% of mortality respectivley so the LD50 by oral route is between 26 and 56.1 mg/kg bw.
Macroscopic examination observation showed that mortality is related to strong corrosivity of CDFA and thus to local effects instead of actual systemic effects.
In these conditions, Chlorodifluoroacetic acid is considered fatal by ingestion according to CLP 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 26 mg/kg bw
- Quality of whole database:
- Key study rated Klimisch 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 14 dec 1989 to 18 apr 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, OECD 402 compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo (69592 L'Arbresle, France)
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 200 to 242 g
- Housing: individual in polycarbonte cages, typeFI (305x180x184 mm)
- Diet (e.g. ad libitum): ad libitum, rat-mice pellets (U.A.R, formule A.04 - U.A.R Villemoison, 91360 Epinay/Orge, France)
- Water (e.g. ad libitum): softened and filtered water (0.6µm), ad libitum
- Acclimation period: 6 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: from 02 jan 1990 to 09 jan 1990 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back or flanks
- % coverage: 10%
- Type of wrap if used: semiocclusive gauze dressing under an elastic bandage (Creplux / Moliner)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
1.31 ml/mg - Duration of exposure:
- 24 hours
- Doses:
- 2004 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1/4 hour after application, then 1, 2 and 4 hours and daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy - Sex:
- male/female
- Dose descriptor:
- LD50
- Based on:
- test mat.
- Remarks on result:
- other: No LD 50 could be determined because product is corrosive
- Mortality:
- Animals were sacrified on day 2, for human reason because Chlorodifluoroacetic acid was corrosive.
- Clinical signs:
- other: None
- Other findings:
- Total necrosis of tissues including skin and muscles.
- Interpretation of results:
- other: LD50 not determined becaude of corrosivity
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Chlorodifluoroacetic acid could not be determined because of its corrosivity.
- Executive summary:
In a GLP study, Chlorodifluoroacetic acid was tested to evaluate the acute toxicity following a single cutaneous adminitration at doses 0 and 2004 mg/kg bw undiluted.
Total necrosis of tissues including skin and muscles was observed at the treatment site.
In these conditions, the LD50 of Chlorodifluoroacetic acid could not be determined because of its corrosivity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- It is the only available study selected as key study.
Additional information
Acute oral toxicity:
No data is available on the reaction mass of chlorodifluoroacetic acid and trifluoroacetic acid as a waiving of this study was done based on the substance corrosivity.
Data are available only on chlorodifluoroacetic acid and the LD50 was between 26 to 56.6 mg/kg (OECD 401). Necropsy showed that the toxic effects are related to the corrosivity of CDFA and thus are actually local effects rather than systemic effects.
However, in a worst case approach, and because the reaction mass CDFA/TFA is mainly composed of CDFA, the result on the CDFA was retained, and the reaction mass is considered as fatal by ingestion, according to the CLP 1272/2008 and toxic by ingestion according to the 67/548/EC directive.
Acute inhalation toxicity:
No data are available on the reaction mass of chlorodifluoroacetic acid and trifluoroacetic acid as a waiving of this study was done based on the substance corrosivity.
The only available study is trifluoroacetic acid alone which is at percentage inferior to 15% in the reaction mass of CDFA/TFA and cannot be used for the reaction mass classification. This study evidenced a NOAEC of 300 mg/m3 for irritation of the upper respiratory tract and no LC 50 was determined.
Based on these results no classification for acute inhalation toxicity is required.
Acute dermal toxicity:
No data are available on the reaction mass of chlorodifluoroacetic acid and trifluoroacetic acid as a waiving of this study was done based on the substance corrosivity.
An experimental study was available on chlorodifluoroacetic acid, but no LD50 was determined due to high corrosivity of the substance.
Based on these results, no LD50 for the reaction mass was determined and no classification for acute dermal toxicity is required.
Justification for classification or non-classification
Based on available results on each component of the reaction mass, the classification of the reaction mass is Fatal by ingestion (Acute oral toxicity category 2 H300) according to the CLP 1272/2000 criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.