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EC number: 938-639-0 | 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:
- 27-10-2014 - 03-11-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guideline under GLP, this was conducted as part of testing plan to meet the China Level III testing requirements
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIL Research stock colony
- Age at study initiation: 10-11 months
- Weight at study initiation: 3491.7 -3767.1 g
- Housing: individually in suspended wire-mesh cages
- Diet: 150 g PMI Nutrition International, LLC, Certified HF Rabbit LabDiet® 5325 per day
- Water: municipal water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6°C to 18.7°C
- Humidity (%): 32.5% to 45.7%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
VEHICLE: NA - Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 7 days (scoring at 30-60 minutes , 24, 48 and 72 hours after treatmeneversible earlier)t and on day 4 and 7 (if not reversable earlier))
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: 2-ply gauze patch secured in place with Micropore™ tape, overwrapped with a gauze binder and secured with Dermiform
tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with deionizedwater
- Time after start of exposure: after the 4 h exposure period
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.9
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days (2 males), 7 days (1 female)
- Remarks on result:
- other: brown discoloration at all scoring times
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- brown discoloration of the applicatoion site at all observations
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin
- Executive summary:
Rabbits (n=3) were treated with 0.5 mL test substance under semi-occlusion for 4 hours. Very slight erythema, which was fully reversible within 4 to 7 days was observed. The substance is considered to be not irritating to the skin.
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:
- 03-11-2014 - 13-11-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed to meet the requirements of the Chinese legislation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Greenfield, IN or Denver, PA
- Age at study initiation: 12 to 17 months
- Weight at study initiation: 4109.7 to 4337.8 g
- Housing: individually in stainless steel cages elevated aboveground corncob bedding
- Diet: 150 g PMI Nutrition International, LLC, Certified Rabbit HF LabDiet® 5325 + one kale leaf 3 times weakly
- Water: municipal water ad libitum
- Acclimation period: 0 - 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.4°C to 18.9°C
- Humidity (%): 32.5% to 39.6%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
VEHICLE : NA - Duration of treatment / exposure:
- NA ( no eye wash performed)
- Observation period (in vivo):
- 3 to 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: macropscopic examination and fluorescein for all cornea observations
TOPICAL ANESTHETICS AND SYSTEMIC ANALGESICS: according to the guideline
60 min before application: buneprophine (0.01 mg/ kg bw s.c.)
5 min before application: 0.5% proparacaine hydrochloride in each eye
8 hours after application: buneprophine (0.01 mg/ kg bw s.c.) and meloxicam (0.5 mg/kg s.c.)
thereafter: buneprophine (0.01 mg/ kg bw s.c.) every 12 hours, combined with meloxicam (0.5 mg/kg s.c.) every 24 hours - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h (2 animals), 7 days (1 animal)
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eye
- Executive summary:
Three rabbits received 0.1 mL test substance in their eye after receiving topical anesthetics and systemic analgesics. No signs of irritation were observed during the 3 to 7 days test period. Slight redness was fully reversed at the end of the observation period. Therefore it is concluded that the substance is not irritating to the eye.
Reference
Animal no |
1 |
2 |
3 |
|||||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
4 |
7 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
1 |
1 |
0 |
2 |
2 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
discharge |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an in vitro test for skin irritation, the relative mean viability of the test item treated tissues was 20.3% after a 15 minute exposure period (Harlan 2013). This would lead to the conclusion that the substance is a skin irritant. In an in vivo study, however, no irritant effects were observed after 4 hour exposure to the rabbit skin (Wil 2015). An in vitro assay for corrosivity showed that the substance is not corrosive (Harlan 2013).
The test item was found to be not irritating in a SkinEthic Reconstructed Human Corneal Epithelial Model study after 10 minutes of exposure.
In a BCOP assay with bovine corneas exposed to the substance opacity and permeability were similar to the negative controls (Harlan 2014).
In an in in vivo test in rabbits was negative (Wil 2015).
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are 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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