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EC number: 603-501-8 | CAS number: 13171-18-1
- 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
In GLP in vivo guideline studies with rabbits, the substance was found to be essentially non-irritating to skin and eyes. The substance does not meet the requirements for classification as corrosive/irritating to skin or damaging/irritating to eyes.
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:
- 29 August 2017 thru 1 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing. - Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or test system and environmental conditions:
- ANIMALS:
Sex: Female, nulliparous and non-pregnant.
Age: Young adult (12 weeks)
Weight: 2358 - 2651 grams at experimental start
Source: Received from Robinson Services, Inc. on 23 August 2017
HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 20 - 23 deg C and 51 - 70% relative humidity
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 6 days
Food: Envigo Teklad Global High Fiber Rabbit Diet #2031; 150 g/day along with a Premium Timothy Cube
Water: Filtered tap ad libitum
IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml applied to 6 cm2 intact dose site.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: 6 cm2
- Type of wrap if used: 1 x 1 guaze pad and 3-inch Micropore tape that covered the pad and entire trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 3% soap solution followed by a tap water rinse and a clean paper towel.
- Time after start of exposure: 4 hours.
OBSERVATION TIME POINTS
- 30 to 60 minutes; 24 hours, 48 hours, and 72 hours after patch removal.
SCORING SYSTEM:
- Draize et al. 1944 and Primary Dermal Irritation Index (PDII) as follows; 0 = non irritating; >0 - 2.0 = Slightly irritating; 2.1 - 5.0 = Moderately irritating; >5.0 = Severely irritating. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The overall Primary Derminal Index (PDII) score = 0.6; slightly irritating.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time.
- Executive summary:
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2500 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time. Therefore, the substance was determined to not meet the criteria for classification as corrosive or 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing. - Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or tissues and environmental conditions:
- ANIMALS:
Sex: Female, nulliparous and non-pregnant.
Age: Young adult (12 weeks)
Weight: 2400 - 2741 grams at experimental start
Source: Received from Robinson Services, Inc. on 23 August 2017
HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 20 - 23 deg C and 68 - 74% relative humidity
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 6 days
Food: Envigo Teklad Global High Fiber Rabbit Diet #2031; 150 g/day along with a Premium Timothy Cube
Water: Filtered tap ad libitum
IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: N/A
SCORING SYSTEM: Draize et. al. 1994.
TOOL USED TO ASSESS SCORE: White light source and fluorescein dye. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 thru 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1 thru 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 thru 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 thru 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not Applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was only slightly irritating in 1 test animal at the 1 hour observation time. This response cleared up by the 24 hour observation time. There were no signs of irritation at the 24, 48, or 72 hour observation times in any of the test animals.
- Executive summary:
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2400 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 1 of 3 animals at the 1-hour observation mark. No signs of irritation remained at the 24 hour observation time and there were no signs of irritation in any of the test animals at the 24, 48, or 72 hour observation times. Therefore, the substance was determined to not meet the criteria for classification as damaging or irritating to the eye.
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
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2500 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 2 of 3 animals at the 24-hour observation mark. No signs of irritation remained at the 48 hour observation time. Therefore, the substance was determined to not meet the criteria for classification as corrosive or irritating to the skin.
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2400 (1998) with 3 young adult female New Zealand Albino rabbits, the test substance was only slighly irritating in 1 of 3 animals at the 1-hour observation mark. No signs of irritation remained at the 24 hour observation time and there were no signs of irritation in any of the test animals at the 24, 48, or 72 hour observation times. Therefore, the substance was determined to not meet the criteria for classification as damaging or irritating to the eye.
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