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EC number: 616-390-6 | CAS number: 76811-98-8
- 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
FEX0-080 was found to be non irritant on rabbit.
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:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to recommended guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Acclimatization: For at least 5 days before the treatment, in the area where the experiment took place. Housing: Animals were housed individually in cages of standard size. Excreta were removed by unrolling plasticized brown paper, previously placed under cages. These cages were placed in an air conditioned (17- 21°C) animal house kept at between 45 % and 65 % relative humidity in which non-recycled filtered air was changed approximately ten times per hour. The artificial day/night cycle was 12 hours light and 12 hours darkness with light on at 7.30 a. m.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- sterile
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of FEX0-080 was applied.
- Duration of treatment / exposure:
- 3 minutes and 1 hour for the first animal.
4 hours for the other ones. - Observation period:
- One hour, 24 hours, 48 hours and 72 hours approximately after removal of the dressing, any skin lesions, which may have developed on the right flank of each animal, was evaluated.
- Number of animals:
- Three animals were treated.
- Details on study design:
- Three animals are required for the complete test. Additional animals may be used to clarify equivocal responses. In case FEX0-080 shows corrosive properties in the first animal the test can be stopped at this stage. Animals will be selected on the basis of their general conditions.
Exposure of one animal:
If it is suspected that the test substance may produce severe irritancy/corrosion to the skin, then initially a single rabbit will be treated. When it is suspected that the test substance may cause corrosion, three test patches will be applied successively to separate skin sites on the animal. A first patch will be removed after three minutes. If no severe skin reaction is observed, a second patch will be applied and removed after one hour. If the observations at this stage indicate that exposure can humanely be allowed to extend to four hours, a third patch will be applied and removed after four hours and the responses will be graded. If a corrosive effect is observed after one of the three sequential exposures, the study will achieve immediately. When it is suspected that the test substance may cause severe irritancy (not corrosion), a single patch will be applied to the animal for four hours.
Exposure of two additional animals:
If neither a corrosive effect or a severe irritant effect is observed after four hours exposure, the test will be completed using two additional animals, each with one patch only, for an exposure period of four hours. Exposure of three animals: I fit is suspected that the test substance will not produce severe irritancy or corrosion, the study may be started using three animals, each receiving one patch for an exposure period of four hours.
The number of animals per group is the minimum number enabling an accurate assessment of the studied toxicological effect. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour - 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour - 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour -24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hour - 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 hour - 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 hour - 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 hours - 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48 hours - 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 48 hours - 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 48 hours - 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 48 hours - 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 48 hours - 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Acute skin lesions - Individual scores
- Irritant / corrosive response data:
- Under the experimental conditions adopted, FEX0-080 was found to be non irritant on rabbit.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions adopted, FEX0-080 was found to be non irritant on rabbit.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified as skin irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritant was evaluated on rabbit according to OECD 404 Guideline. Under the experimental conditions adopted, FEX0-080 was found to be non irritant.
Justification for classification or non-classification
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified as skin irritant.
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.
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