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Diss Factsheets
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EC number: 460-360-3 | 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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: method described in Official newspaper of FrenchRepublic (1982-02-22)
- GLP compliance:
- yes
- Species:
- rabbit
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of treatment / exposure:
- 24 h
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 72 d; Max. value at end of observation period: 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 72 d; Max. value at end of observation period: 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Interpretation of results:
- other: not classified
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: clinical quotation
- Deviations:
- no
- Principles of method if other than guideline:
- The clinical quotation is made 30 minutes after the patch removal and takes in account the erythema, the papules, the vesicles and the blisters. According to their intensity, the quotation is spread out from 0 to 3. The total sum of the scores, divided by the number of volunteers, defines the mean irritation index (M.I.I.), which allows to classify arbitrarily the test item into “non irritant, slightly irritant, moderately irritant, very irritant and severely irritant"
- GLP compliance:
- no
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Normal skin without any dermatological lesion on the experiental area
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Single application of 5 mg of the studied test item pure on the external face of the arm
- Duration of treatment / exposure:
- 48h in contact with the skin, with the help of a semi-occlusive patch
- Observation period:
- Clinical quotation made 30 minutes after the patch removal
- Number of animals:
- 20 volunteers of the female or male sex from 18 to 65 years old
- Irritation / corrosion parameter:
- other: other: mean irritation index (M.I.I)
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: other: human. Time point: 48 hours. Reversibility: no data. (migrated information)
- Other effects / acceptance of results:
- The mean irritation index (MII) of the test item is 0. The test item can be considered as non-irritant
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
Referenceopen allclose all
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:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: Methode officicelle pour l'evaluation de l'irritation oculaire
- Version / remarks:
- Method described in J.O. of 10/07/92
- Principles of method if other than guideline:
- Methode officicelle pour l'evaluation de l'irritation oculaire
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albinos
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 1h, 24h, 48h and 72h
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Comments:This test was realized by a laboratory which is not certified by BPL.
The observation of ocular lesions was not pursued beyond 72 hours after the product application. At
this time, it remained an eryhtema of conjonctiva level 1 in one rabbit.
Given the weak irritation, there is no need to think that this substance could cause an irreversible effect.
It is not appeared a justification to make this test again. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only
one significant and usual reaction of conjonctiva without no particular consequence. Considering the
small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official
numerical classification, the product is completely lacking in any irritant effect for the ocular mucous
membrane - Executive summary:
The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only
one significant and usual reaction of conjonctiva without no particular consequence. Considering the
small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official
numerical classification, the product is completely lacking in any irritant effect for the ocular mucous
membrane
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- other justification
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.