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EC number: - | CAS number: 1474044-66-0
- 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
The substance is irritating to the skin and eyes of rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Common functional groups
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached justification
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached justification
4. DATA MATRIX
Please refer to attached justification - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h. Slight eschar formation at 72h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1st reading 0.5h after 24h dosing. no reading at 48 h.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 3.13
- Max. score:
- 8
Reference
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:
- 15 - 18 August 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA, USA
- Age at study initiation: 'young adults'
- Weight at study initiation: 2.27-2.48 kg
- Housing: Wire mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 31% - Duration of treatment / exposure:
- eyes not rinsed after instillation
- Observation period (in vivo):
- 24, 48, 72 hours post instillation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: no rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: not rinsed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results of this study, the test article is a primary eye irritant according to 16 CFR 1500.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A reliable skin irritation study performed using C8 alkane sulfonate and read across to the substance is available [FDRL (1985)]. In this study, performed to 16 CFR 1500.41, 0.5 mL of a 31 % solution of the alkane sulfonate was applied under occlusive conditions to the skin (abraded and intact) of New Zealand White rabbits for 24 hours. The skin was observed for signs of irritation 24.5 and 72 hours after dosing. Mean erythema scores for intact skin of 2.0 and 3.3 were seen at 24.5 and 72 hours, respectively. Oedema scores of 0.83 and 0 were seen at these same time points. It is anticipated that the effects would be reversed in a 14 -day observation period. On the basis of these results, the substance is classified as a Category 2 skin irritant.
A reliable eye irritation study performed using C8 alkane sulfonate and read across to the substance is available [FDRL (1985)]. In this study, performed to 16 CFR 1500.42, 0.1 mL of a 31% solution of the alkane sulfonate was instilled into the eyes of New Zealand White rabbits. Eyes were not rinsed and were examined at 24, 48 and 72 hours for signs of irritation. The mean scores for each animal for these time points ranged between 0.67-1 for cornea and iris, 2-3 for conjunctivae and 2-3.7 for chemosis. These effects were not fully reversible within 72 hours. It is anticipated that the effects would be reversed in a 21 -day observation period. On the basis of these results, the substance is classified as a Category 2 eye irritant.
Justification for classification or non-classification
The substance is classified as Skin Irritant Category 2 on the basis of the reactions seen in the in vivo skin irritation study.
The substance is classified as Eye Irritant Category 2 on the basis of the reactions seen in the in vivo eye irritation study.
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