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EC number: 217-589-7 | CAS number: 1897-52-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 April 1992 to 17 April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to GLP and was conducted in compliance with the standard test guideline OECD 405 with no deviations thought to affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (see "Principles of method if other than guideline" for more information)
- Principles of method if other than guideline:
- Deviations from the protocol, which do not affect the quality of the relevant results are as follows:
- The test animals were obtained from a supplier other than stated in the protocol.
- Due to malfunction of the thermeohygrograph the temperature and the relative humidity in the animal room were not recorded on 12 April 1992.
- Due to the low melting point it was not possible to weigh the filled syringes, before the test material solidified.
- The lot number was not given on the test material container but confirmed by an internal memorandum. It therefore was not specified on the raw data. - GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6-difluorobenzonitrile
- EC Number:
- 217-589-7
- EC Name:
- 2,6-difluorobenzonitrile
- Cas Number:
- 1897-52-5
- Molecular formula:
- C7H3F2N
- IUPAC Name:
- 2,6-difluorobenzonitrile
- Details on test material:
- Physical state: white paste
Storage condition of test material: prior to dosing the test material was stored in a refrigerator
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan CPB, Zeist, The Netherlands (bred at the R.I.V.M., Bilthoven, The Netherlands
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel wire cages
- Diet: standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands ad libitum
- Water: ad libitum
- Acclimation period: 5 days prior to study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (ºC): 20-21 ºC
- Humidity (%): 20-60%
- Air changes (per hr): approximately 16
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark
IN-LIFE DATES: From 14 April 1992 to 17 April 1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test material was melted prior to application
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- - Dose administration: test material was placed (via syringe) in the conjunctival sac of the left eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was added. The lids were then gently held together for a few seconds after which the animal was released and returned to its cage. The right eye, remaining untreated, served as a control.
- Observation period (in vivo):
- Animals were observed for 72 hours following treatment.
- Number of animals or in vitro replicates:
- Three male rabbits were used in the study.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation was not performed
SCORING SYSTEM
The reactions observed were scored in accordance with the criteria of Draize (1944), presented as Table 1 in the field " Any other information on materials and methods incl. tables".
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hr readings
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hr readings
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hr readings
- Score:
- 0
- Max. score:
- 20
- Irritant / corrosive response data:
- At 24 hours after application of the test material a fold of the cornea across the whole eye was observed in one rabbit. No adverse effects were observed hereafter. The numerical grades awarded to the eye reactions elicited by the test material are given in Table 2 in the field "Any other information on results incl. tables".
Any other information on results incl. tables
Table 2: Scores of the Irritation Reactions after Application of 0.1 ml diflubenil to the Eye of Three Rabbits
Animal No. | Region of the eye | Hours (h) after treatment | Mean | ||||||
Pretest | 1 h | 24 h | 48 h | 72 h | |||||
1 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 | 0 | |
Area involved | 0 | 0 | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 0 | 0 | 0 | 0 | 0 | 0 | ||
Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | |||
Discharge | 0 | 0 | 0 | 0 | 0 | 0 | |||
2 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 | 0 | |
Area involved | 0 | 0 | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 0 | 0 | 0 | 0 | 0 | 0 | ||
Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | |||
Discharge | 0 | 0 | 0 | 0 | 0 | 0 | |||
3 | Cornea | Opacity | 0 | 0 | 0a | 0 | 0 | 0 | |
Area involved | 0 | 0 | 1 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 0 | 0 | 0 | 0 | 0 | 0 | ||
Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | |||
Discharge | 0 | 0 | 0 | 0 | 0 | 0 |
aA fold of the cornea across the whole eye
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material caused no significant eye irritation in any of the animals and the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The irritation of the test material to the rabbit eye was investigated following standard test guideline OECD 405. 0.1 ml of test material was placed into the conjunctival sac of one eye of each of three male rabbits. The eyes of the rabbits were examined and the ocular reactions graded at 24 hour intervals up to and including 72 hours post treatment. At 24 hours after application of the test material a fold of the cornea across the whole eye was observed in one rabbit. No adverse effects were observed hereafter.
The test material caused no significant eye irritation in three rabbits. The test material is therefore classified as a non-irritant to the eye and does not require classification for eye irritation in line with Regulation No. 1272/2008.
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