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EC number: 206-839-0 | CAS number: 381-73-7
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The substance difluoroacetic acid does not exhibit repeated dose toxicity by oral,inhalation and dermal route.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: Subchronic;Chronic
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: NTP long-term
- Principles of method if other than guideline:
- OECD QSAR Toolbox 3.1 prediction; Read Across; 5 nearest analogs; Log Kow discriptor
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- No data
- Remarks:
- Doses / Concentrations:
95.09 mg/kg
Basis:
nominal in water - No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- LOEL
- Effect level:
- 95.1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: histopathologic changes occurring in the livers of mice
- Critical effects observed:
- not specified
- Conclusions:
- The oral drinking administration of difluoroacetic acid to mouse, at a dose level of 95.09 mg/kg bw/day, resulted in low observed effect.
Thus the LOEL for repeated dose toxicity study was considered to be 95.09 mg/kg bw/day. - Executive summary:
The oral drinking administration of difluoroacetic acid to mouse, at a dose level of 95.09 mg/kg bw/day, resulted in low observed effect.
Thus the LOEL for repeated dose toxicity study was considered to be 95.09 mg/kg bw/day.
Reference
The prediction was based on dataset comprised from the following descriptors: "study LOEL","effect LOEL","study NOEL",LOEL,"NOEL calculated",NOEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((("a" or "b" or "c" or "d" or "e" or "f" ) and ("g" and ( not "h") ) ) and ("i" and ( not "j") ) ) and ("k" and ( not "l") ) ) and "m" ) and ("n" and "o" ) )
Domain logical expression index: "a"
Referential boundary: The target chemical should be classified as Group 14 - Carbon C AND Group 16 - Oxygen O AND Group 17 - Halogens F AND Group 17 - Halogens F,Cl,Br,I,At by Chemical elements
Domain logical expression index: "b"
Referential boundary: The target chemical should be classified as PFOA by OECD HPV Chemical Categories
Domain logical expression index: "c"
Referential boundary: The target chemical should be classified as Alkyl halide AND Carboxylic acid by Organic functional groups
Domain logical expression index: "d"
Referential boundary: The target chemical should be classified as Alkyl halide AND Carboxylic acid AND Overlapping groups by Organic functional groups (nested)
Domain logical expression index: "e"
Referential boundary: The target chemical should be classified as Acid, aliphatic attach [-COOH] AND Alcohol, olefinic attach [-OH] AND Aliphatic Carbon [CH] AND Carbonyl, aliphatic attach [-C(=O)-] AND Fluorine, aliphatic attach [-F] AND Miscellaneous sulfide (=S) or oxide (=O) AND Olefinic carbon [=CH- or =C<] by Organic functional groups (US EPA)
Domain logical expression index: "f"
Referential boundary: The target chemical should be classified as Alkyl fluoride AND Alkyl halide AND Carbonic acid derivative AND Carboxylic acid AND Carboxylic acid derivative AND Halogen derivative by Organic functional groups, Norbert Haider (checkmol)
Domain logical expression index: "g"
Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.1
Domain logical expression index: "h"
Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Acyl transfer via nucleophilic addition reaction OR Acylation >> Acyl transfer via nucleophilic addition reaction >> Isocyanates and isothiocyanates OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> Acid anhydrides OR Acylation >> Direct acylation involving a leaving group >> Acyl halide of carboxylic acids OR Acylation >> Direct acylation involving a leaving group >> Carbamates OR Acylation >> Direct acylation involving a leaving group >> N-acylamides OR Acylation >> Direct acylation involving a leaving group >> N-acylated heteroaromatic amines OR Acylation >> Direct acylation involving a leaving group >> N-acylsulphonamides OR Acylation >> Direct acylation involving a leaving group >> Phosphonyl halides OR Acylation >> Direct acylation involving a leaving group >> Sulphonyl halides OR Acylation >> Ester aminolysis OR Acylation >> Ester aminolysis >> Amides OR Acylation >> Ester aminolysis or thiolysis OR Acylation >> Ester aminolysis or thiolysis >> Activated alkyl or aryl esters OR Acylation >> Ester aminolysis or thiolysis >> Diarylesters OR Acylation >> Ring opening acylation OR Acylation >> Ring opening acylation >> Active cyclic agents OR Michael addition OR Michael addition >> a,b-unsaturated carbonyl compounds OR Michael addition >> a,b-unsaturated carbonyl compounds >> a,b-unsatuarted aldehydes OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-carbonyl compounds with polarized double bonds OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> Cyanoalkenes OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> Nitroalkenes OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> N-sulfonylazomethyne compounds OR Michael addition >> Michael addition on conjugated systems with electron withdrawing group >> Vinyl sulfonyl compounds OR Michael addition >> Michael type addition on vinyl pirydines and activated ethenylarenes OR Michael addition >> Michael type addition on vinyl pirydines and activated ethenylarenes >> Activated electrophilic ethenylarenes OR Michael addition >> Michael type addition on vinyl pirydines and activated ethenylarenes >> Vinyl pyridines OR Michael addition >> Michael-type addition on azoxy compounds OR Michael addition >> Michael-type addition on azoxy compounds >> Azoxy compounds OR Michael addition >> Quinone type compounds OR Michael addition >> Quinone type compounds >> Quinone (di)imines OR Nucleophilic addition OR Nucleophilic addition >> Addition to Carbon-hetero double/triple bond OR Nucleophilic addition >> Addition to Carbon-hetero double/triple bond >> Ketones OR Radical OR Radical >> Free radical formation OR Radical >> Free radical formation >> Organic peroxy compounds OR Schiff base formation OR Schiff base formation >> Nucleophilic cycloaddition to diketones OR Schiff base formation >> Nucleophilic cycloaddition to diketones >> Diketones OR Schiff base formation >> Pyrazolones and pyrazolidinones derivatives OR Schiff base formation >> Pyrazolones and pyrazolidinones derivatives >> Pyrazolones and pyrazolidinones OR Schiff base formation >> Schiff base formation with carbonyl compounds OR Schiff base formation >> Schiff base formation with carbonyl compounds >> Aldehydes OR SN1 OR SN1 >> Carbenium ion formation OR SN1 >> Carbenium ion formation >> Azoxy compounds-forming carbenium ion OR SN2 OR SN2 >> Interchange reaction with sulphur containing compounds OR SN2 >> Interchange reaction with sulphur containing compounds >> Thiols and disulfide compounds OR SN2 >> Nucleophilic substitution at Nitrogen atom OR SN2 >> Nucleophilic substitution at Nitrogen atom >> N-nitroso compounds OR SN2 >> Nucleophilic substitution at sp3 Carbon atom OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Activated alkyl esters OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> alpha-activated haloalkanes OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> alpha-haloalkanes OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> N-nitroso compounds OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Phosphonates OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Sulfonates OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Thiophosphates OR SN2 >> Nucleophilic substitution on benzylic carbon atom OR SN2 >> Nucleophilic substitution on benzylic carbon atom >> alpha-activated benzyls OR SN2 >> Nucleophilic substitution on heterocyclic sulfenamides OR SN2 >> Nucleophilic substitution on heterocyclic sulfenamides >> Heterocyclic sulfenamides OR SN2 >> Nucleophilic substitution to the central carbon atom of N-nitroso compounds OR SN2 >> Nucleophilic substitution to the central carbon atom of N-nitroso compounds >> N-nitroso compouns excluding aromatic OR SN2 >> Ring opening SN2 reaction OR SN2 >> Ring opening SN2 reaction >> Epoxides, Aziridines and Sulfuranes OR SNAr OR SNAr >> Nucleophilic aromatic substitution on activated halogens OR SNAr >> Nucleophilic aromatic substitution on activated halogens >> Activated haloarenes by Protein binding by OASIS v1.1
Domain logical expression index: "i"
Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD
Domain logical expression index: "j"
Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct Acylation Involving a Leaving group OR Acylation >> Direct Acylation Involving a Leaving group >> Acetates OR SN2 OR SN2 >> SN2 reaction at sp3 carbon atom OR SN2 >> SN2 reaction at sp3 carbon atom >> alpha-Halo ethers OR SNAr OR SNAr >> Nucleophilic aromatic substitution OR SNAr >> Nucleophilic aromatic substitution >> Activated halo-pyridines by Protein binding by OECD
Domain logical expression index: "k"
Referential boundary: The target chemical should be classified as Halogens AND Non-Metals by Groups of elements
Domain logical expression index: "l"
Referential boundary: The target chemical should be classified as Alkali Earth by Groups of elements
Domain logical expression index: "m"
Similarity boundary:Target: C(=O)(O)C(F)F
Threshold=10%,
Dice(Atom centered fragments)
Domain logical expression index: "n"
Parametric boundary:The target chemical should have a value of log Kow which is >= -1.76
Domain logical expression index: "o"
Parametric boundary:The target chemical should have a value of log Kow which is <= 3.15
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 95.09 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- mouse
- Quality of whole database:
- k2 level data as the end point obtained from QSAR estimation
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: estimated data
- Principles of method if other than guideline:
- Data is predicted by QSAR toolbox version 3.1
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 5 (Weeks/Days)
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- LOEL
- Effect level:
- 179.552 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: changed in enzyme activity
- Critical effects observed:
- not specified
- Conclusions:
- Repeated dose toxicity LOEL (Lowest observed effect level) of difluoroacetic acid in rat by the inhalation route was found at a dose concentration of 179.551742554 mg/kg/day .
- Executive summary:
Repeated dose toxicity LOEL (Lowest observed effect level) of difluoroacetic acid in rat by the inhalation route was found at a dose concentration of 179.551742554 mg/kg/day .On the basis of this LOEL it is concluded that the test substance is not toxic to rat by oral route below the mentioned dose.
Reference
The prediction was based on dataset comprised from the following descriptors: "effect LOEL"
Estimation method: Takes average value from the 6 nearest neighbours
Domain logical expression:Result: In Domain
(((("a" or "b" or "c" or "d" ) and ("e" and ( not "f") ) ) and ("g" and ( not "h") ) ) and ("i" and "j" ) )
Domain logical expression index: "a"
Referential boundary: The target chemical should be classified as Low (Class I) by Toxic hazard classification by Cramer (original)
Domain logical expression index: "b"
Referential boundary: The target chemical should be classified as Alkyl halide AND Carboxylic acid by Organic functional groups
Domain logical expression index: "c"
Referential boundary: The target chemical should be classified as Alkyl halide AND Carboxylic acid AND Overlapping groups by Organic functional groups (nested)
Domain logical expression index: "d"
Referential boundary: The target chemical should be classified as Alkyl fluoride AND Alkyl halide AND Carbonic acid derivative AND Carboxylic acid AND Carboxylic acid derivative AND Halogen derivative by Organic functional groups, Norbert Haider (checkmol)
Domain logical expression index: "e"
Referential boundary: The target chemical should be classified as Not possible to classify according to these rules (GSH) by Protein binding potency
Domain logical expression index: "f"
Referential boundary: The target chemical should be classified as Highly reactive (GSH) OR Highly reactive (GSH) >> Acrylates (MA) OR Slightly reactive (GSH) OR Slightly reactive (GSH) >> Methacrylates (MA) by Protein binding potency
Domain logical expression index: "g"
Referential boundary: The target chemical should be classified as Non binder, non cyclic structure by Estrogen Receptor Binding
Domain logical expression index: "h"
Referential boundary: The target chemical should be classified as Non binder, without OH or NH2 group by Estrogen Receptor Binding
Domain logical expression index: "i"
Parametric boundary:The target chemical should have a value of log Kow which is >= -0.463
Domain logical expression index: "j"
Parametric boundary:The target chemical should have a value of log Kow which is <= 1.68
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 179.551 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- k2 level data as the end point obtained from QSAR estimation
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
WoE Summary of 381-73-7 for repeated dose toxicity
Repeated dose toxicity (Oral):
Based on the various studies available with Klimish rating 2 for the read across substances for CAS: 381-73-7 based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. This data is combined with the prediction done using the QSAR toolbox for the target chemical based on similar category approach, the results is summarized as follows
Sr. No |
End point |
Value |
Species |
Route |
Effects |
Remarks |
1 |
LOEL |
95.09 mg/ kg bw/ d |
Mouse |
Oral |
histopathologic changes occurring in the livers of mice |
Predicted data |
2 |
LOAEL |
50 mg/ kg bw/ d |
Mouse |
Oral |
No significant differences in body weight were observed |
Data from publication for RA 631-64-1 |
3 |
NOEL |
5 mg/ kg bw/ d |
Rat |
Oral |
Body weight changes |
Data from publication for RA 79-43-6 |
4 |
LOEL |
50 mg/ kg bw/ d |
Rat |
Oral |
Body weight changes, total serum protein decrease, increase in liver & kidney organ to body weight ratios |
Data from publication for RA 79-43-6 |
5 |
LOEL |
604.17 mg/ kg bw/ d |
Rat |
Oral |
body weight decreased |
Predicted data |
Based on the studies summarized in the above table with oral routes it can be observed that lowest effect value (LOAEL & LOEL) varies from 50 - 604.17 mg/kg bw/d based on the predicted data for the target well as data for read across. Also the predicted value of LOEL is estimated to be 95 mg/Kg bw/d which falls within the range of the LOAEL value and considered to valid prediction. The effects observed on the this doses was listed as follows
· Histopathologic changes occurring in the livers of mice
· No significant differences in body weight were observed
· Body weight changes
· Body weight changes, total serum protein decrease, increase in liver & kidney organ to body weight ratios
· Body weight decreased
Thus based on above discussion it can be concluded that substance CAS: 381-73-7 is expected to show the similar toxicological effect based on the effects observed on the other category members. Since the Low effective dose value (LOEL) is 95.09 mg/Kg bw/d thus based on this value it can be concluded that substance difluoroacetic acid is considered to be not toxic to repeated dose below the dose level of 95.09 mg/kg bw/d. On the basis of this LOEL value it is concluded that the test substance is not toxic to rat by the oral route below the mentioned dose. Also there is no known evidence of adverse effect on Human of difluoroacetic acid as well as mechanistic triggers does not classify this substance as toxic substance.
Repeated dose toxicity (Inhalation):
Based on the predicted data with Klimish rating 2 for target substance for difluoroacetic acid based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox.
The LOEL value 179.55 mg/kg bw/d predicted on rabbit shows effects on the change in enzyme activity
On the basis of this LOEL value it is concluded that the test substance is not toxic via inhalation route for the above mentioned dose.
Repeated dose toxicity (Dermal):
The substance is unlikely to have a direct skin contact moreover the physicochemical and toxicological properties suggest low potential of significant rate of absorption through the skin. Further the substance is used as an intermediate in preparation of pharmaceutical chemicals, thereby there is low toxicity potential. This intrinsic property can be extrapolated to repeated dose administration and thus dermal route administration can be waived off.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Repeated dose toxicity LOEL (Lowest observed effect level) of difluoroacetic acid in mouse (B6C3F1) by the oral route was estimated at a dose concentration of 95.09 mg/kg /day.On the basis of this LOEL it is concluded that the test substance is not toxic tomouse (B6C3F1) by oral route below the mentioned dose.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Repeated dose toxicity LOEL (Lowest observed effect level) of difluoroacetic acid in rat by the inhalation route was found at a dose concentration of 179.551742554 mg/kg/day .On the basis of this LOEL it is concluded that the test substance is not toxic to rat by oral route below the mentioned dose.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The substance is unlikely to have a direct skin contact moreover the physicochemical and toxicological properties suggest low potential of significant rate of absorption through the skin. Further the substance is used as an intermediate in preparation of chemicals, thereby there is low toxicity potential. This intrinsic property can be extrapolated to repeated dose administration and thus dermal route administration can be waived off
Justification for classification or non-classification
The substance difluoroacetic acid not show repeated dose toxicity effect for oral,dermal and inhalation route and thus will not be considered for further classification.
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.
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