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EC number: 221-518-5 | CAS number: 3130-19-6
- 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/ Corrosion: Read-Across Substance
Based on these results, the test material was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.
Eye Irritation: Read-Across Substance
Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.
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:
- 02 June 1992 to 24 August 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Number of animals used was in excess of guideline minimum
- Principles of method if other than guideline:
- Not relevant
- 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: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg (males) and 2.6 to 3.5 kg (females)
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in.).
- Diet: ad libitum except during the actual dosing period.
- Water: Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.
IN-LIFE DATES: From: 02 June 1992 To: 16 June 1992 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hour exposure period.
- Observation period:
- 14 days
(Animals were observed at 1, 24, 48 and 72 hours and 7 and 14 days) - Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: Not documented - test site was circa 2.5 x 2.5 cm
- Type of wrap if used: Polyethylene sheeting was placed loosely over the gauze patch on which the test material was applied.
- Following application of the test material, the animals were placed in a restraining device for the 4 hour contact period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): As much excess test material was removed as possible
- Time after start of exposure: Following the 4 hour exposure period.
SCORING SYSTEM: Draize scoring method - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Application of 0.5 mL of the test material to covered rabbit skin for a 4-hour contact period produced minor erythema on 6 of 6 rabbits. Minor transient oedema was produced on 3 animals. There was no oedema present on any animal by 2 days. Erythema subsided on all rabbits within 14 days.
- Other effects:
- There was no irreversible tissue destruction noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test material was not considered to be a skin irritant. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008 as the criteria were not fulfilled for erythema and oedema.
- Executive summary:
In a study conducted by Myers et al, (1992), the test material was investigated for its potential to act as a skin irritant. The study was performed in accordance with the standardised guideline OECD 404, under GLP conditions.
The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5mL of the test material was applied via a gauze patch. Polyethylene sheeting was wrapped around the test site to create an impermeable barrier. The contact period with the test material was 4 hours after which, as much excess test material as possible was removed.
The modified primary irritation score was 1.35. Minor erythema was observed on all 6 rabbits directly after the 4 hour contact period. Minor transient oedema was evident on 3 animals but it had subsided fully by day 2. Erythema had subsided fully within 14 days. Based on these results, the test material was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Read across to substance with the same functional groups.
- Reason / purpose for cross-reference:
- read-across source
Referenceopen allclose all
Using the EU criteria for assessing skin irritation the mean score for 24, 48 and 72 hours for erythema was 0.833 and for oedema was 0.17. Recovery was complete within 14 days for erythema and within 2 days for oedema.
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:
- 02 June 1992 to 24 August 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across to substance with the same functional groups.
- Reason / purpose for cross-reference:
- other: read-across target
- 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: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg or 2.6 to 3.5 kg for males and females respectively
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in).
- Diet: diet was available ad libitum except during the actual dosing period.
- Water: Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 hour light / dark cycle.
IN-LIFE DATES: From: June 2, 1992 To: June 11, 1992 - Vehicle:
- not specified
- Controls:
- other: the untreated eye of each animal served as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- 9 days
- Observation period (in vivo):
- 9 days
(Animals were observed at 1, 24, 48 and 72 hours and at 7 and 9 days following instillation) - Number of animals or in vitro replicates:
- 4 rabbits (2 males and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented
SCORING SYSTEM: Draize (1959) scoring method.
TOOL USED TO ASSESS SCORE: Fluorescein staining performed on day 1 and at each subsequent examination days. - Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- 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:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritant / corrosive response data:
- A volume of 0.1 mL of test material instilled into rabbit eyes produced no corneal injury or iritis in any of 4 rabbit eyes dosed. Minor conjunctival irritation was observed in all 4 rabbits within 1 hour. The dosed eye of 1 rabbit healed by 48 hours. The 3 remaining rabbits had a normal ocular appearance within 72 hours to 9 days.
- Other effects:
- No additional effects observed.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not eye irritating
- Conclusions:
- Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.
- Executive summary:
In a study conducted by Myers et al., (1992),the test material was investigated for its potential to act as an eye irritant. The study was conducted in accordance with the standardised guideline OECD 405, under GLP conditions.
0.1mL of the test material was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test material was not removed so the exposure period was 9 days. Following exposure, no corneal injury or iritis in any of 4 rabbit eyes dosed was observed. Minor conjunctival irritation was observed in all 4 animals within one hour, with the dosed eye of 1 rabbit healing by 24 hours and the 3 remaining rabbits had a normal appearance within 72 hours to 9 days.
Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Read across to substance with the same functional groups.
- Reason / purpose for cross-reference:
- read-across source
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/ Corrosion: Read-Across Substance
In a study conducted by Myers et al, (1992), the test material was investigated for its potential to act as a skin irritant. The study was performed in accordance with the standardised guideline OECD 404, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5mL of the test material was applied via a gauze patch. Polyethylene sheeting was wrapped around the test site to create an impermeable barrier. The contact period with the test material was 4 hours after which, as much excess test material as possible was removed.
The modified primary irritation score was 1.35. Minor erythema was observed on all 6 rabbits directly after the 4 hour contact period. Minor transient oedema was evident on 3 animals but it had subsided fully by day 2. Erythema had subsided fully within 14 days. Based on these results, the test material was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.
Eye Irritation: Read-Across Substance
In a study conducted by Myers et al., (1992), the test material was investigated for its potential to act as an eye irritant. The study was conducted in accordance with the standardised guideline OECD 405, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
0.1mL of the test material was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test material was not removed so the exposure period was 9 days. Following exposure, no corneal injury or iritis in any of 4 rabbit eyes dosed was observed. Minor conjunctival irritation was observed in all 4 animals within one hour, with the dosed eye of 1 rabbit healing by 24 hours and the 3 remaining rabbits had a normal appearance within 72 hours to 9 days.
Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye corrosion or irritation.
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