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EC number: 635-156-4 | CAS number: 109293-98-3
- 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
No skin irritation potential as well as no eye irritation potential was determined in two skin irritation studies and in two eye irritation studies with the test substance and the read-across test substance (free acid of Diflufenzopyr sodium salt).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-23 until 1995-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reliable study, similar to current OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- November, 1984
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2.1 to 2.8 kg
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°c
- Humidity: 30 - 70 %
- Air changes: 19 air changes per hour
- Photoperiod: 12 hours of artificial light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with 0.5 ml distilled water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours after test substance application
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 100 mm X 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing on the moistened gauze pads
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean scores of animals 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean scores of animals 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-30 until 1995-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reliable study, similar to current OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire. England
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: a standard laboratory diet SDS Stanrab (P) Rabbit, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 - 70 %
- Air changes: approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye remained untreated as a control
- Amount / concentration applied:
- 50 mg of the test substance
- Duration of treatment / exposure:
- Until end of the observation period
- Observation period (in vivo):
- 1, 2, 3, 24, 48, 72 hours and 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 7 rabbits
- Details on study design:
- SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (mean scores of animals 1-6)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.05
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
One animal was not considered in the results/scores presented above (results of 6 animals presented instead of 7) as the animal was not treated as the rest of the animals (pre test). The treated eye of this animal was washed, in opposite to the other treated eyes of the other animals. No irritation/ corrosion effects were observed in the washed eye of this animal.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin
Key study
A study was performed to assess the skin irritation potential of a formulation of the test substance to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81-5. Six rabbits were administered a single dermal dose of 0.5 g in a semi-occlusive application and observed for four days. Very slight dermal irritation was observed. The reactions had resolved by day 2 or 3.
Supporting study
A study was performed to assess the skin irritation potential of read-across test substance (free acid of Diflufenzopyr sodium salt) to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81-5. Six rabbits were administered a single dermal dose of 0.5 g in a semi-occlusive application and observed for four days. No dermal reactions occured.Eye
Key study
A study was performed to assess the eye irritation potential of a formulation of the test substance to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81- 4. Seven rabbits were each administered a single ocular dose of 0.5 g of the test substance and observed for seven days after instillation. A transient mild to well-defined conjunctival irritation was observed. All reactions had resolved 1 or 2 days after instillation.
Supporting study
A study was performed to assess the eye irritation potential of the read-across test substance (free acid of Diflufenzopyr sodium salt) to the rabbit, according to the Pesticide Assessment Guidelines, EPA 81- 4. Seven rabbits were each administered a single ocular dose of 0.3 g of the test substance and observed for seven days after instillation. Dulling of the cornea and mild conjunctival irritation were observed. All reactions had resolved 1 or 2 days after instillation.Justification for selection of skin irritation / corrosion endpoint:
Most reliable study
Justification for selection of eye irritation endpoint:
Most reliable study
Justification for classification or non-classification
Based on data available the test substance is not classified for skin and eye irritation according to the criteria of Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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