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EC number: 241-972-8 | CAS number: 18063-03-1
- 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
Oral route: The LD50 was 1075 mg/kg bw for female rats and 2576 mg/kg bw for male rats.
Dermal route: The LD50 was >2000 mg/kg bw for male and female rats.
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:
- key study
- Study period:
- Sep - Oct 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, near guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K., Ltd.
- Age at study initiation: 9 to 11 weeks
- Fasting period before study: animals were fasted overnight (18 hours)
- Weight at study initiation: 190 g (males) and 138 g (females)
- Housing: single sex groups of 2-3 in cages with stainless-steel wire-mesh floors and tops; each cage measured 38 x 25 x 18 cm
- Diet: PRD (Labsure animal Foods, Dorset, UK), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% in DMSO (m/v) - Doses:
- 780-3200 mg/kg bw
- No. of animals per sex per dose:
- 780 mg/kg bw: 4
1250 mg/kg bw: 8
1500 mg/kg bw: 4
2000 mg/kg bw: 8
2500 mg/kg bw: 4
3200 mg/kg bw: 4 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days;
- Frequency of observations and weighing: Observations were recorded three times a day for the first three days and daily thereafter. The initial (i.e. day 1), day 7 and day 14 body weights were recorded;
- Necropsy of survivors performed: no;
- Other examinations performed: clinical signs and body weight. - Statistics:
- prohibit analyis
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 576 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: given the disparity in response between males and females, a combined LD50 values is not quoted
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 075 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: given the disparity in response between males and females, a combined LD50 values is not quoted
- Mortality:
- 780 mg/kg bw: males: 0/4; females: 0/4
1250 mg/kg bw: males: 0/8; females: 6/8
1500 mg/kg bw: males: 0/4; females: 4/4
2000 mg/kg bw: males: 1/8; females: 8/8
2500 mg/kg bw: males: 1/4; females: 4/4
3200 mg/kg bw: males: 4/4; females: 4/4 - Clinical signs:
- other: The incidence and duration of clinical signs were dose-related. The commonest clinical signs seen indicated a neurological action since they included gait and posture abnormalities and prostration, the sequela to the latter being coma in some cases.
- Gross pathology:
- Not investigated.
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in female rats was calculated to be 1075 mg/kg bw and in male rats 2576 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test substance was investigated in Fischer 344 rats. The test substance was administered orally by gavage at 780, 1250, 1500, 2000, 2500 and 3200 mg/kg bw. Animals were subjected to observations and determination of the body weight. Mortality occurred at concentrations from 1250 up to 3200 mg/kg bw in females and from 2000 up to 3200 mg/kg bw in males. The incidence and duration of clinical signs were dose-related. The commonest clinical signs seen indicated a neurological action since they included gait and posture abnormalities and prostration, the sequela to the latter being coma in some cases. All surviving animals had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.
The acute oral median lethal dose (LD50) of the test item in female rats was calculated to be 1075 mg/kg bw and in male rats 2576 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 075 mg/kg bw
- Quality of whole database:
- The whole database is of good quality.
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, near guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K., Ltd.
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 220 g (males) and 151 g (females)
- Housing: single sex groups of 2-3 in cages with stainless-steel wire-mesh floors and tops; each cage measured 38 x 25 x 18 cm
- Diet: PRD (Labsure animal Foods, Dorset, UK), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Vehicle:
- other: moistened powder
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal site
- % coverage: 60% of dorsal site
- Type of wrap if used: aluminium foil lined with gauze , fixed by a double overwrap of waterproof adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: with warm dilute detergent solution and then dried
- Time after start of exposure: 24 h - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- 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 and weighing: Observations were recorded three times a day for the first three days and daily thereafter. The initial (i.e. day 1), day 7 and day 14 body weights were recorded;
- Necropsy of survivors performed: no;
- Other examinations performed: clinical signs and body weight. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: no effects
- Gross pathology:
- not investigated
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the median lethal dose of the test item after dermal application was found to be greater than 2000 mg/ka bw.
- Executive summary:
The acute dermal toxicity of the test item was evaluated on the basis of a study similar to the OECD guideline 402.
There were no clinical signs and all rats had gained weight relative to their day 1 bodyweights ba the end of the 14 day observation perios. None of the rats died from which it was concluded that the acute dermal median lethal dose (LD50) of the test item, applied as a moistened powder, in rats was greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The whole database is of good quality.
Additional information
Oral toxicity
In an acute oral toxicity study comparable to OECD guideline 401, rats (Fisher 344, 4-8/sex/dose) were exposed to 780-3200 mg/kg bw 2,6-difluorobenzamide in DMSO (50%) by gavage and were observed for 14 days (Sittingbourne Research Centre, 1987). The incidence and duration of clinical sings were dose-related. The commonest clinical signs observed indicated a neurological action since they included gait and posture abnormalities and prostration, the sequela to the latter being coma in some cases. All surviving animals had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period. Mortality figures were as follows: no mortality was observed at 780 mg/kg bw in both sexes, 0/8 males and 6/8 females died at 1250 mg/kg bw, 0/4 males and 4/4 females died at 1500 mg/kg bw, 1/8 males and 8/8 females died at 2000 mg/kg bw, 1/4 males and 4/4 females died at 2500 mg/kg bw and 4/4 males and 4/4 females died at 3200 mg/kg bw. No gross pathology was performed. The LD50 was 2576 mg/kg bw in male rats and 1075 mg/kg bw in female rats.
Dermal toxicity
In an acute dermal toxicity test, comparable to OECD guideline 402, rats (Fisher 344, 5/sex) were treated with 2000 mg/kg bw 2,6-difluorobenzamide applied as a moistened powder for 24 hours and subsequently observed for a 14-day period (Sittingbourne Research Centre, 1987). No mortality, clinical signs or effects on bodyweight were observed. No gross pathology was performed. The LD50 was determined to be >2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Most reliable study.
Justification for selection of acute toxicity – dermal endpoint
Most reliable study.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC with Xn, R22.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for acute toxicity under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013, the classification is H302, Cat. 4.
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