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EC number: 275-069-5 | CAS number: 70969-58-3
- 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
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with internationally recognised test guidelines
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 41 - 43 weeks
- Weight at study initiation: 4.3 - 5.2 kg
- Housing: single housing in polycarbonate/stainless steel cages
- Diet (e.g. ad libitum): Stanrab (P) SQC from Special Diet Services available ad libitum
- Water (e.g. ad libitum): Municipal supply available ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2013-01-27 To: 2013-02-12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted (as supplied)
VEHICLE
- Not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 x 25 mm area of skin clipped free of hair on the dorsal and lateral parts of the trunk of the animals
- % coverage: Not applicable to test method
- Type of wrap if used: Surgical gauze tape 25 x 25 mm (soaked with test substance) held in place by non-irritating tape. The application area was then immobilised with an elastic adhesive dressing acting as a semi-occlusive barrier
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale according to OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n/a
- Irritant / corrosive response data:
- No erythema or oedema was recorded in all animals approximately 1 hour after treatment. Well defined erythema (score 2) was observed in all animals approximately 24, 48 and 72 hours after dosing. Animals showed slight erythema (score 1) at observation performed on Day 8 of the study. Recovery occurred in all animals at the end of the observation period (Day 15).
AVERAGE SCORE
- Erythema: 2.0
- Edema: 0.0 - Other effects:
- There was no indication of a systemic effect
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No systemic effects were observed. Well defined erythema was observed in all animals following treatment which had recovered completely by the end of the 14-day observation period. The observed iritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.
- Executive summary:
Dermal irritation following a 4 hour exposure period has been assessed in accordance with OECD/EU test methods.
No systemic effects were observed. Well defined erythema was observed in all animals following treatment which had recovered completely by the end of the 14-day observation period. The observed iritation was not of sufficient severity or duration for the substance to require classification as a skin irritant.
Reference
Irritant/corrosive response data for each animal at each observation time of each animal from the test
Time point |
Erythema |
Oedema |
Max. score: 4 |
Max. score: 4 |
|
60 minutes |
0/0/0 |
0/0/0 |
24 hours |
2/2/2 |
0/0/0 |
48 hours |
2/2/2 |
0/0/0 |
72 hours |
2/2/2 |
0/0/0 |
7 days |
1/1/1 |
0/0/0 |
14 days |
0/0/0 |
0/0/0 |
Average 24, 48 and 72 hours |
2.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- June 18-21, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with internationally recognised test guidelines
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: conventional, singly housed in metal cages with perforated noryl floors
- Diet (e.g. ad libitum): Stanrab (P) from Special Diet Services UK, ad libitum
- Water (e.g. ad libitum): Municipal supply ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2012-06-18 To: 2012-06-21 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: Draize scale, acording to test guideline
TOOL USED TO ASSESS SCORE: None - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0 - Other effects:
- Slight conjunctival redness observed in all 3 animals and slight discharge observed in 1 animal 1 hour after exposure. Recovery occurred within 24 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute eye irritation has ben investigated in the rabbit using methods in accordance with OECD/EU test guidelines. No significant irritation was observed.
- Executive summary:
Acute eye irritation has ben investigated in the rabbit using methods in accordance with OECD/EU test guidelines. No significant irritation was observed.
Reference
Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 minites |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
24 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
48 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 hours |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24, 48, 72 hours |
0.0 |
0.0 |
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
Acute dermal irritation has been assessed in the rabbit using OECD/EU test methods. The irritation observed was not of sufficient severity or persistence for the substance to require classification as a skin irritant.
Acute eye irritation has been assessed in the rabbit using OECD/EU test methods. The severity and persistence of ocular response was not sufficient for the substance to require classification as an eye irritant.Justification for selection of skin irritation / corrosion endpoint:
Single study available for evaluation
Justification for selection of eye irritation endpoint:
Single study available for evaluation
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
Observed response in both a skin irritation study and an eye irritation study was not of sufficient severity or persistence to require classification aacoding to the criteria of EC Regulation No. 1272/2008.
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