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EC number: 500-744-0 | CAS number: 162492-10-6 1 - 6.5 moles propoxylated
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 February 2015 - 23 March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine
- EC Number:
- 500-744-0
- EC Name:
- Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine
- Cas Number:
- 162492-10-6
- Molecular formula:
- (C3H8O3) (C3H6O)m(C3H2O)n ( C4H11N)o ; m (1-6) ; n (1-3) , o (1-3)
- IUPAC Name:
- Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: CEGAV, Argenvilliers, France
- Age at study initiation: at the beginning of the study, the animals were 2 to 4 months old
- Mean body weight at study initiation: 2623 g ± 196.2 g
- Housing: individually housed in noryl cages
- Diet: 110 pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)
IN-LIFE DATES: 10 March 2015 to 23 March 2015.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL/flank. - Duration of treatment / exposure:
- 3 min, 1 h, 4 h.
- Observation period:
- 1, 24, 48 and 72 h after removal of the dressing; if relevant, daily until reversibility of reactions
- Number of animals:
- Three males.
- Details on study design:
- TEST SITE
- Area of exposure: two or four areas of skin (3.5 cm x 5 cm) on the right and left anterior and/or posterior flanks of animals
- Coverage: 6 cm2
- Type of wrap if used: gauze pad held in place by a non-irritation semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: using a dry cotton pad
- Time after start of exposure: at removal of each dressing (see Duration of exposure).
SCORING SYSTEM:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure)
- Any other lesions were noted
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: Day 4
- Remarks on result:
- other: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean )
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: Day 7
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean )
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- After a 4-hour exposure (three animals), a very slight erythema was noted in 1/3 animals on Days 2 and 3 and in the two other animals from Day 1 to Day 3 or 6. Dryness of the skin was recorded in 2/3 animals from Day 2 or 3 until Day 6.
Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. erythema: 0.7, 0.7, 1.0; showing slight irritating properties but no significant inflammation,
. edema: 0.0, 0.0, 0.0; showing no inflammation. - Other effects:
- No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.
The body weight of the animals was unaffected by the test item treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test item was non-irritant when applied topically to rabbits.
- Executive summary:
The objective of this study was to evaluate the potential corrosive and irritant properties of the test item following dermal application on rabbits.
This study was conducted in compliance with the principles of Good Laboratory Practice.
Methods
The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit.
After the 4-hour application, since the mean value from grading at 24, 48 and 72 hours after patch removal was < 2.3 for erythema and for edema, the test item was applied on the skin of two otheranimalsfor 4 hours.
A dosage-volume of 0.5 mL/flank was used.
The test item was placed on a gauze pad, which was then applied to a skin area of approximately 6 cm2. The gauze pad was held in place by a non-irritation semi-occlusive dressing and a restraining bandage. After required period of contact with the skin, the dressing was removed.
Each animal was observed once a day for mortality and clinical signs. For each exposure period, cutaneous reactions were evaluated approximately 1, 24, 48 and 72 hours after removal of the dressingand then daily until the reversibility of cutaneous reactions. The mean values of the scores for erythema and edema were calculated for each animal. Body weight was recorded on the day of treatment and at the end of the evaluation of cutaneous reactions.
On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.
Results
No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.
The body weight of the animals was unaffected by the test item treatment.
After a 4-hour exposure (three animals), a very slight erythema was noted in 1/3 animals on Days 2 and 3 and in the two other animals from Day 1 to Day 3 or 6.
Dryness of the skin was recorded in 2/3 animals from Day 2 or 3 until Day 6.
Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. erythema: 0.7, 0.7, 1.0; showing slight irritating properties but no significant inflammation,
. edema: 0.0, 0.0, 0.0; showing no inflammation.
Conclusion
Under the experimental conditions of this study, the test item was non-irritant when applied topically to rabbits. Therefore, the test item should not be classified as irritating to skin according to the criteria of CLP Regulation.
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