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EC number: 485-270-1 | 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- 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
In an in vivo eye irritation study the test item was shown to be non-irritant to the skin.
In an in vivo eye irritation study the test item produced slightly irritating effects, which were fully reversible within 2 days.
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:
- 22 Feb 2007 (date of Project Protocol) - 11 April 2007 (date of Report)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 April, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Storage conditions: at room temperature
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Animal 1: 2,9 kg; Animal 2: 2.3 kg; Animal 3: 3.0 kg
- Housing: Semi-barrier in an air conditioned room, ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogen free (TPF)
- Water: Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: adequate acclimatization period
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- rel. Humidity: 55 ± 10%
- Air changes: at least 10x / hour
- Photoperiod (hrs dark / hrs light): artificial light: 12 h light, 12 h dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Test item was applied to a small area of skin on one side of the dorsal area, the untreated other side served as control.
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Test item was applied to a small area (approx. 6 cm²) of skin on one side of the dorsal area
- Type of wrap if used: covered with a gauze patch, which was held in place with non-irritating tape.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after patch removal
SCORING SYSTEM:
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. Dermal irritation was scored and recorded according to grades of the classification system below:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef-redness) to eschar
formation preventing grading of erythema 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extending
beyond exposure area) 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test item showed neither irritant nor corrosive effects on the intact skin of the three rabbits.
- Other effects:
- There were no significant body weight changes during the contact and observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vivo skin irritation test performed according to OECD/EC guidelines and GLP principles, the substance was concluded to be non-irritant to the skin.
Reference
Body Weight
Animal No. | Start of Study (Weight kg) | End of Study (Weight kg) |
1 | 2.9 | 3.0 |
2 | 2.3 | 2.4 |
3 | 3.0 | 3.1 |
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:
- 22 Feb 2007 (Date of Project Protocol) - 19 Apr 2007 (Date of Report)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Storage conditions: at room temperature
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: Animal 1: 4.0 kg; Animal 2: 2.8 kg; Animal 3: 2.7 Kg
- Housing: ABS - plastic rabbit cages, floor 4200 cm²
- Diet: free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre (TPF)
- Water: free access to tap water
- Acclimation period: adequate acclimatization period
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3°C
- Humidity: 55±10%
- Air changes: at least 10x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye severed as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The animals were observed for 72 hours after dosing.
The eyes were examined for signs of irritation throughout the observation period. Eye irritation was scored and recorded.
For calculation only the 24, 48 and 72 hour readings were used.
72 hours after administration the treated eyes were examined with the aid of a fluorescein solution. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h post instillation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- 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 2 days.
- Other effects:
- No toxic effect was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo eye irritation test, performed according to OECD/EC guidelines and GLP principles, the test item produced slightly irritating effects, which were reversible within 48 hours.
Reference
Body Weight
Animal No. | Start of Study (Weight kg) | End of Study (Weight kg) |
1 | 4.0 | 4.0 |
2 | 2.8 | 2.9 |
3 | 2.7 | 2.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data, the test substance does not require classification for skin or eye irritation according to Regulation (EC) No 1272/2008.
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