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Diss Factsheets
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EC number: 433-470-4 | CAS number: -
- 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
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:
- November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed in accordance with GLP and following OECD 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:
- 3 animals of one sex were used.
Animals used within the study were at least 6 weeks old and body weights were between 1.0 and 3.5Kg.
Identification: Earmark - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Test substance was ground to a powder usign a pestle and mortar prior to weighing and the test substance was moistened with 0.4ml water (Mill-U) immediately before application to ensure close contact with the animals skin.
0.5g of test substance was applied. - Duration of treatment / exposure:
- Four hours after the application of test substance, the dressing was removed and the skin cleaned of residual test substance using water.
- Observation period:
- Mortality / Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application).
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. - Number of animals:
- 3 animals of one sex.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal #925
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal #926
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal #927
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal #925
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal #926
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal #927
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours exposure to SETAFIX X 11342
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Guideline in commission Directive 93/21/EEC
- Conclusions:
- No skin irritation was caused by 4 hours exposure to SETAFIX X 11342.
- Executive summary:
No skin irritation was caused by 4 hours exposure to SETAFIX X 11342
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Carried out to GLP standards and according to OECD guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals used within the study were at least 6 weeks old and body weights were between 1.0 and 3.5Kg.
Identification: Earmark - Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test substance (solid) was ground to a powder prior to weighing.
- Controls:
- not required
- Amount / concentration applied:
- 72.0+/-0.3mg of test substance was applied.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instiallation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area. - Number of animals or in vitro replicates:
- Three animals
- Details on study design:
- The irritation was assessed according to a numerical scoring system for
Corneal Irritation - Opacity and area
Iris
Conjunctival irritation - redness, chemosis and discharge
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an opthalmic examination lamp. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours in one animal and 72 hours in the other animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 2 out of 3 animals had a max score of 1 at 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 48 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 2 out of 3 animals had a max score of 1 at 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, SETAFIX X 11342 does not have to be classified and has no obligatory labelling requirement for eye irritation.
- Executive summary:
Based on these results and according to the EC criteria for classification and labelling requirments for dangerous substances and preparations, SETAFIX X 11342 does not have to be classified and has no obligatory labelling requirement for eye irritation.
Reference
Corrosion: There was no evidence of ocular corrosion.
Colouration: No staining of (peri) ocular tissues by the test substance was observed.
Remnants of the test substance were present in the eyes of all animals on day 1.
Toxicity/ mortality: No symptoms of sytemic toxicity were observed in the animals during the test period and no mortaility occured.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
No skin irritation effects were seen after 24 hours exposure.
Justification for selection of eye irritation endpoint:
No eye irritation was seen beyond 48 hours in all cases and all
effects were fully reversed within 72 maximum for all test animals.
Justification for classification or non-classification
No skin irritation effects were seen after 24 hours exposure.
No eye irritation was seen beyond 48 hours in all cases and all effects were fully reversed within 72 maximum for all test animals.
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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