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EC number: 485-300-3 | 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
not irritant to skin (500 mg) nor to eye (100 mg);
Respiratory irritation: waived = hazard unkown (no further information required) - qualitative RC (anti-dust protection)
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:
- from 2007-12-20 till 2007-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2004/73/EG, B.4
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- rbt, New Zealand White HsdIf:HZW
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- other: aqua ad inject
- Controls:
- other: The untreated other side served as control.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- none
- Other effects:
- No effects observed.
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item showed no irritant/corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
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
- Study period:
- from 2007-11-21 till 2008-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2004/73/EG, B.5
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand White Rabbits HsdIf:NZW
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated contralateral eye served as control
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0.33 - <= 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0.33 - <= 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 4 days
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item
produced slightly to obviously irritating effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An acute Dermal Irritation/Corrosion test with the test substance was performed according to OECD 404,Directive 2004/73/EC B.4 with rabbits.
The test item was held in contact with the skin throughout a 4-hour period. A dose of 0.5 g of the test item was applied to each test site. Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 24, 48 and 72 hours after patch removal.
The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits (strain NZW) after a contact time of 4 hours. There were no significant body weight changes during the contact and observation period. The Primary Irritation Index (PII) was 0.
An acute Eye Irritation/Corrosion test with the test substance was performed according to OECD 405,2004/73/EG, B.5 with rabbits.
In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of 3 female NZW - rabbits (HsdIf:NZW) at a dose of 0.1 g per application site. The untreated other eye served as control. Observations were calculated and compared to the control eyes, 24 h, 48 h, 72 h post-dose. The observation period was prolonged until no signs of irritation were recorded (animal no. 1 and 2: 72 hours, animal no. 3: 96 hours post instillation). Animal no. 1 showed redness and chemosis grade 2 and discharge grade 1 of the conjunctivae 1 h after instillation. 24 h post instillation redness grade 2 and chemosis grade 1 of the conjunctivae were recorded. 24 h post instillation no discharge was recorded. 48 h post instillation redness grade 1 was recorded.
No symptoms were observed 72 hours post instillation. Animal no. 2 showed redness and discharge grade 1, chemosis grade 2 of the conjunctivae 1 h after instillation. After 24 h redness grade 1 of the conjunctivae, but no signs of chemosis and discharge were recorded.
No symptoms were observed 48 hours post instillation. Animal no. 3 showed redness, chemosis and discharge grade 2 of the conjunctivae 1 h and 24 h after instillation. 48 h after instillation redness and discharge grade 1 of the conjunctivae were recorded. 72 h after instillation redness grade 1 of the conjunctivae was recorded; no signs of dicharge were recorded.
No symptoms were observed 96 hours post instillation. No other toxic effects were observed. The eyes were not rinsed. Throughout the observation period no weight loss was recorded in the test animals. The calculated mean scores did not exceed the limit values according to Directive 93/21 EEC in any case.
Justification for selection of skin irritation / corrosion endpoint:
only existing study is sufficient
Justification for selection of eye irritation endpoint:
only existing study is sufficient
Justification for classification or non-classification
According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding irritation/corrosion.
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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