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EC number: 947-155-9 | CAS number: -
- 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:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- No data
- Deviations:
- no
- Remarks:
- No deviations ocurred that impacted the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate
- EC Number:
- 947-155-9
- Molecular formula:
- C11H20O2
- IUPAC Name:
- Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate
- Test material form:
- liquid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 11
- Purity, including information on contaminants, isomers, etc.: 99.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Kept in a room with controls set to maintain 18°C to 24°C
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
None, dosed neat.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
: The test article was dosed neat.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Inc.
- Age at study initiation: 1.5
- Weight at study initiation: 3.9-4.3 kg
- Housing: Individually housed in stainless steel cages elevated above corncob bedding.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified High Fiber Rabbit Diet 5325. Approximately 150 g/day was offered during the study.
- Water (e.g. ad libitum): Tap water, treated by reverse osmosis and UV irradiation, ad libitum.
- Acclimation period: At least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22 C
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 July, 2019 To: 22 July, 2019
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
NEGATIVE CONTROL : No treatment
POSITIVE CONTROL : None - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations were made at 24, 48 and 72 hours post patch removal and 4, 7, 14, 18 and 21 days post-removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin
- Type of wrap if used: 2-ply gauze patch secured in place with surgical porous tape. The patches were overwrapped with a gauze binder and secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of 4 hours, the bandages were removed and the sites wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 hours.
OBSERVATION TIME POINTS
Observations were made at 24, 48 and 72 hours post patch removal and 4, 7, 14, 18 and 21 days post-removal.
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 5 days
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 8 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 15 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 19 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 22 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 5 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 8 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 15 days
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 19 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 22 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 5 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 8 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 15 days
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 19 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 22 days
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- No edema was observed in animal 1 at any observation point through 22 days during the study
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- No edema was observed in animal 2 at any observation point through 22 days during the study
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- No edema was observed in animal 3 at any observation point through 22 days during the study
- Irritant / corrosive response data:
- Average erythema individual scores (24, 48, and 72 hours) were 1.67, 2.0, and 1.33. Significant erythema persisted during days 15-19 for all three animals. No edema was observed. The Primary Irritation Index (PII) was 1.3.
- Other effects:
- - Other adverse local effects:
Skin flaking was overved in animal 1 at Day 15.
- Other adverse systemic effects: None.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The Primary Irritation Index (PII) was 1.3. The 24, 48, and 72 hours erythema scores indicate a Cat. 3. However, given the irritation seen at days 15-19, MTDID 44430 will be classified as a Skin 2 per GHS and CLP.
- Executive summary:
The skin irritation potential of MTDID 44428 was examined in a study conducted according to OECD 404 in compliance with OECD GLP. New Zealand White rabbits (N = 3) received a single, 4-hour, semi-occluded exposure of 0.5 mL MTDID 44428, which was applied to clipped, unabraded skin. Application sites were evaluated at approximately 30-60 minutes and 24, 48, and 72 hours after patch removal, and 4, 7, 14, 18, and 21 days after removal (Days 5, 8, 15, 19, and 22, respectively). There were no deaths or remarkable body weight changes noted during the study. Average erythema individual scores (24, 48, and 72 hours) were 1.67, 2.0, and 1.33. Significant erythema persisted during days 15-19 for all three animals. No edema was observed. The Primary Irritation Index (PII) was 1.3. The 24, 48, and 72 hours erythema scores indicate a Cat. 3. However, given the irritation seen at days 15-19, MTDID 44430 will be classified as a Skin 2 per GHS and CLP.
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