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EC number: 428-710-1 | CAS number: 207574-76-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.0 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg of the compound were applied and covered with gauze patches in a size of about 2.5 cm x 2.5 cm.
This was wettened with 10 mL warmed water. - Duration of treatment / exposure:
- 4 h
- Observation period:
- The treated areas of the animals were examined 1 hour after patch removal. Thereafter, the readings have been repeated every 24 hours. The final control of localization has been carried out after 7 days.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches were fixed with the help of adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was touched away with a wet towel
- Time after start of exposure: 1 h
SCORING SYSTEM:
1. Erythema and formation of scabs:
- No erythema: 0
- slight erythema (scarcely visible): 1
- Moderate to significant erythema: 3
- Severe erythema (red purple) with formation of slight scabs (deep lesions): 4
2. Formation of oedema:
- No oedema: 0
- Very slight oedema (scarcely visible): 1
- Slight oedema (well defined outlines, swelling apparent): 2
- Moderate oedema (thickness about 1 mm): 3
- Severe oedema (thickness more than 1 mm and area larger than of the square): 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Irritant / corrosive response data:
- No deviations from the normal findings have been observed during the whole experiment on any animal on the shave skin localizations.
- Other effects:
- No test-substance related findings were observed during the weighting of the animals after 7 days.
- Interpretation of results:
- other: not irritating according to Regulation (EC) 1272/2008
- Conclusions:
- As no skin reaction was induced over a period of 7 days, the test item is considered as not skin irritating. Based on these results and according to the EC criteria for classification and labelling, Regulation (EC) No. 1272/2008, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
- Executive summary:
As no skin reaction was induced over a period of 7 days in a GLP study acc. to OECD guideline no. 404, test item is considered as not skin irritating.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.2 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- Readings of eye alterations were made after 1, 2, 4, 8, 24, 48, 72 hours.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Before and after the test, the eyes of all animals were examined under UV. After weighing (16 hours starved) 0.1 g of the substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
The eye lesions were scored according to the system of Draize.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was not removed
SCORING SYSTEM:
1. Cornea
a) Degree of opacity (A):
- No opacity (nor loss of brilliancy or lustre): 0
- Presence of an irritated area of diffused or disseminated appearance, details of the iris clearly visible: 1
- Presence of a translucid, irritated area easily identifiable, details of the iris slightly obscured: 2
- Presence of an opalescent, irritated area, details of the iris visible, outline of the pupil can scarcely be observed: 3
- Presence of opacity making the iris invisible: 4
b) Area of opacity (B):
- 1/4 (or less), but not zero: 1
- Between 1/4 and 1/2: 2
- Between 1/2 and 3/4: 3
- From 3/4 to the whole area: 4
The total mark is determined by multiplying the two scores by 5: A X B x 5 (maximum = 80)
2. Iris (C)
- Normal: 0
- Clearly more plicate than normal, congestion, swelling circumcorneal injection (one or several of these characteristics), iris still reacting to light (a slow reaction is a positive reaction): 1
- No reaction to light, heamorrhage, significant "destruction" (one, several or all of these characteristics): 2
The total mark is determined by multyplying the score by 5: C x 5 (maximum = 10)
3. Conjunctiva, Chemosis and Lacrimation
a) Conjuctiva (D):
- Reddening of the palpebral conjunctiva: vessels normal: 0
- Vessels clearly more injected than normal: 1
- Bright red colour, more diffuse, vessels difficult to distinguish: 2
- Diffuse blood red colour: 4
b) Chemosis (E):
- No swelling: 0
- Slight swelling, including the nictating membrane: 1
- Pronounced swelling, with inversion of the eyelid: 2
- Swelling with eyelids half closed: 3
- Swelling with eyelid closed more than half-way or completely closed: 4
c) Lacrimation (F):
- Absence: 0
- Slight lacrimation (do not take into account slight secretions normally in the inside corner): 1
- Lacrimation with moistening of the eyelids and hairs around the eyelids: 2
- Lacrimation with moistening of the eyelids and heirs on wide areas around the eye: 3
The total mark is determined by adding the three scores and multiplication of the sum by 2: (D + E + F) x 2 (maximum = 20)
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: iridal changes were not evident
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: cornea opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: chemosis was not evident during the study
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Some conjunctiva redness (up to scores of 2) and some lacrimation were observed in all rabbit until 8h after application
- Other effects:
- Body weights and body weight gains were normal in all animals.
- Interpretation of results:
- other: not irritating according to Regulation (EC) 1272/2008.
- Conclusions:
- Based on the results and according to the EC criteria for classification and labelling according to GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement as irritating to eyes.
- Executive summary:
As no eye reaction were observed in a GLP study acc. to OECD guideline no. 405 at 24, 48 and 72 h,
the test item is considered as not eye irritating.
Reference
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
Since no classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) are fulfilled, the substance is not classified for skin and/or eye irritation/corrosion.
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