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EC number: 448-060-0 | CAS number: 727678-39-9
- 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
Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
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:
- 12 Aug - 22 Aug 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Japanese test guidelines (12 Nousan, Notification No 8147, November 2000)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 1407 - 1570 g
- Housing: Animals were housed individually in cages with perforated floors.
- Diet: approximately 100 g/d Charles River Breeding and Maintenance Diet for Rabbits (Altromin) and pressed hay (twice a week)
- Water: tap water, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 23.9
- Humidity (%): 46 - 89
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 50 % (v/v) aqueous solution of ethanol
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test substance moistened with 0.5 mL of the vehicle - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the dorsal area of one flank
- Type of wrap if used: The treated skin was covered with a metalline patch mounted on Micropore tape, that was wrapped around the abdomen and held in place with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with ethanol.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24,48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- other: mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- At 1 and 24 h after the dermal application of the test substance, slight erythema formation (score 1) was observed in 1/3 animals. The observation was reversible within 48 h. No further erythema formation was observed at any other reading time point. The treatment with the test substance did not result in edema formation in any of the animals tested at any reading time point.
- Other effects:
- All animals survived and no symptoms of systemic toxicity were observed in the animals during the test period. No staining of the treated skin by the test substance was observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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:
- 18 Aug - 23 Aug 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Japanese guidelines
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 - 9 weeks
- Weight at study initiation: 1546 - 2032 g
- Housing: Animals were housed individually in cages with perforated floors.
- Diet: approximately 100 g/d Charles River Breeding and Maintenance Diet for Rabbits (Altromin) and pressed hay (twice a week)
- Water: tap water, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 23.2
- Humidity (%): 40 - 96
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 34.8 - 38.3 mg, what corresponds to a volume of approximately 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- other: mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Instillation of the test substance into one eye of each of the three rabbits resulted in effects on the iris and conjunctivae. The iris of all animals showed slight irritation at the 1 h reading timepoint. This effect was reversible within 24 h. On the conjunctivae of all animals, slight redness (score 2) and chemosis (score 2) was observed at the 1 h reading timepoint. Within 24 h, the conjunctivae of all animals recovered and showed slight redness (score 1) and chemosis (score 1). The chemosis was fully reversible within 48 h, whereas the slight redness of the conjunctivae (score 1) resolved within 72 h in all animals.
No corneal opacity was observed and treatment of the eyes with 2% fluorescein 24 h after test substance instillation revealed no corneal epithelial damage in any of the animals. - Other effects:
- All animals survived and no symptoms of systemic toxicity were observed in the animals during the test period. No staining of ocular and peri-ocular tissues by the test substance was observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 1. Results of eye irritation study.
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
|||
redness |
swelling |
redness |
swelling |
||||||||
1
|
1 |
2 |
2 |
1 |
0 |
|
|||||
24 |
1 |
1 |
0 |
0 |
|||||||
48 |
1 |
0 |
0 |
0 |
|||||||
72 |
0 |
0 |
0 |
0 |
|||||||
average |
0.67 |
0.33 |
0 |
0 |
Time to reversion |
72 |
48 |
24 |
0 |
||
2
|
1 |
2 |
2 |
1 |
0 |
|
|
||||
24 |
1 |
1 |
0 |
0 |
|||||||
48 |
1 |
0 |
0 |
0 |
|||||||
72 |
0 |
0 |
0 |
0 |
|||||||
average |
0.67 |
0.33 |
0 |
0 |
Time to reversion |
72 |
48 |
24 |
0 |
||
3
|
1 |
2 |
2 |
1 |
0 |
|
|
||||
24 |
1 |
1 |
0 |
0 |
|||||||
48 |
1 |
0 |
0 |
0 |
|||||||
72 |
0 |
0 |
0 |
0 |
|||||||
average |
0.67 |
0.33 |
0 |
0 |
Time to reversion |
72 |
48 |
24 |
0 |
||
|
|
||||||||||
|
Time [h] |
conjunctivae
|
iris |
cornea |
|||||||
|
redness |
swelling |
|
|
avg. time to reversion |
72 |
48 |
24 |
0 |
||
average score |
1 |
2 |
2 |
1 |
0 |
|
|||||
24 |
1 |
1 |
0 |
0 |
|||||||
48 |
1 |
0 |
0 |
0 |
|||||||
72 |
0 |
0 |
0 |
0 |
|||||||
24+48+72 |
0.67 |
0.33 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritating potential of UY-330 was investigated in a study performed according to OECD 404 and GLP (Hooiveld, 2003). The test substance moistened with 0.5 mL of an aqueous ethanol solution (50% v/v) was applied on the clipped skin of three male New Zealand White rabbits. The treated skin was covered semi-occlusive with a metalline patch mounted on Micropore tape and fixed with an elastic bandage. The dressing was removed after 4 h and the treated skin was cleaned with ethanol.
Edema and erythema formation were assessed 1, 24, 48 and 72 h after removal of the test substance using the Draize scoring system. At 1 and 24 h post application, slight erythema formation was observed in one animal. This reaction was reversible within 48 h. The other animals showed no erythema formation and no edema formation was observed in any animal at all. Under the test conditions, the test substance was not irritating to the skin.
The eye irritating potential of UY-330 was tested in a study performed by Hooiveld (2003) in accordance with OECD 405 and GLP. The unchanged powdery test substance was instilled in one eye of each of three male New Zealand White rabbits without washing afterwards. The other eye was not treated and served as control.
The grades of ocular reaction (conjunctivae redness, conjunctivae chemosis, cornea, iris) were assessed 1, 24, 48 and 72 h after instillation of the test substance.
At 1h post application, the iris of all animals showed very slight irritation and the conjunctivae of all animals showed slight redness and chemosis. The iris of all animals recovered within 24 h, the chemosis was fully reversible within 48 h and the redness resolved within 72 h in all animals.
No corneal opacity was observed at all. Under the test conditions, the test substance was not irritating to the eyes.
Justification for selection of skin irritation / corrosion endpoint:
Only one study is available.
Justification for selection of eye irritation endpoint:
Only one study is available.
Justification for classification or non-classification
The available data on skin irritation and eye irritation of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for 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.
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