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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (see "principles of method if other than guideline" box below)
- Principles of method if other than guideline:
- Deviations
- The test animals were obtained from a supplier other than stated in the protocol.
- Due to a malfunction of the thermeohygrograph the temperature and the relative humidity in the animal room were not recorded on 12 April 1992.
- The lot number was not given on the test material container but confirmed by an internal memorandum. It therefore was not specified in the raw data.
These deviations were not considered to have affected the integrity of the study performed. - 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:
- Description: white paste
Storage conditions of test substance: refrigerated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan CPB, Zeist, The Netherlands
- Age at study initiation:
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands ad libitum
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (ºC): 20-21 ºC
- Humidity (%): 20-60 %
- Air changes (per hr): approximately 16
- Photoperiod (hrs dark / hrs light): 12 hrs light (artificial), 12 hours dark
IN-LIFE DATES: From: 14 April 1992 To: 17 April 1992
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- the test material was melted and 0.5g was applied to the patch using a syringe. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours post administration
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² patch.
- Type of wrap used: the patch was sustained by occlusive Blenderm tape and secured in place with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): patches were removed and skin was wiped to remove any remaining test substance.
- Time after start of exposure: 4 hours
SCORING SYSTEM
- The Draize scale (Draize 1959), presented as table 1 in the field "Any other information on material and methods incl. tables" was used to assess the degree of erythema and oedema at the application sites at 30 minutes and at 24, 48 and 72 hours after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 minutes
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 mins, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was seen in all animals 30 minutes after application, and in one animal at 24 hours. There were no other signs of skin irritation. All irritation scores are presented in table 2 in the field "Any other information on results incl. tables".
Any other information on results incl. tables
Table 2: Erythema and Oedema Scores
Animal No. | Erythema | Oedema | ||||||||
Time after decontamination | Mean score | Time after decontamination | Mean Score | |||||||
30 min | 1 day | 2 days | 3 days | 30 min | 1 day | 2 days | 3 days | |||
1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 1 | 1 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0 | 0 |
The mean values have been calculated using the day 1, 2 and 3 values.
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 did not elicit any reaction in any of the animals during the course of the study and the test material does not require classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin irritation of the test material was determined in accordance with the standardised guideline OECD 404. Three rabbits received a single four hour application of 0.5g of the test material and were assessed for at 30 minutes, 24, 48 and 72 hours after treatment for any signs of skin irritation. Very slight erythema was seen in all animals 30 minutes after removal of test material and very slight erythema was seen in one animal after 24 hours. There were no other signs of skin irritation.
Under the conditions of the study, the test material is considered to be practically non-irritating to the skin and does not require classification for skin irritation in line with Regulation No. 1272/2008.
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