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EC number: 953-513-5 | 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 19 to June 3, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- N/A
- Molecular formula:
- C10H16O2
- Test material form:
- liquid
- Remarks:
- Colorless
- Details on test material:
- Test substance was expected to be stable for the duration of testing.
Constituent 1
- Specific details on test material used for the study:
- - lot number of test material:
CH-DA-01-18
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Stored refrigerated
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
Test substance was expected to be stable for the duration of testing.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis:
The test substance was applied as received
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium:
The test substance was applied as received
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
Mixed well prior to use
- Preliminary purification step (if any):
None
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc.
- Age at study initiation: 14 weeks
- Weight at study initiation: 2584-2870 grams
- Housing:
The animals were singly housed in suspended stainless steel caging, which conforms to the size recommendations in the most recent Guidefor the Care and Use ofLaboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum):
PMI 5326 High Fiber Rabbit Diet. A designated amount of the diet (approximately 150 grams/day) and alfalfa hay cubes (Grainland Select Alfalfa Cubes) were available to each rabbit.
- Water: Filtered tap water was supplied ad libitum
- Acclimation period: 14 or 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 49 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Five-tenths of a millilitre
- Duration of treatment / exposure:
- 3 minutes, 1 hour, and 4 hours
- Observation period:
- All dose sites were evaluated for corrosion 30-60 minutes after patch removal. Subsequent evaluations were performed approximately 24, 48, 72 hours and at 7 days after removal of the four-hour patch.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 Cm2
- coverage: 1-inch x 1-inch, 4-ply gauze pad.
- Type of wrap if used: semi-occlusive 3-inch Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3% soap solution followed by tap water and a clean paper towel
- Time after start of exposure: 3 minutes, 1 hour, and 4 hours
OBSERVATION TIME POINTS
30-60 minutes; 24, 48, 72 hours and at 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- Average values for three rabbits.
- Time point:
- other: 30-60 minutes; 24, 48 and 72 hours
- Score:
- 1.7
- Reversibility:
- fully reversible
- Remarks:
- All animals were free of dermal irritation by Day 7 (study termination).
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- No visible necrosis (corrosion) of the skin tissue was observed at the 3-minute, 1-hour and 4-hour
dose sites during the study. In the 3-minute exposure site, within 30-60 minutes of patch removal, very slight erythema was noted at the 3-minute exposure site, which resolved by 24 hours.
In 1 hour exposure site, within 30-60 minutes of patch removal, very slight erythema was noted at the 1-hour exposure site. The overall incidence and severity of irritation decreased with time. Dermal irritation cleared from the treated site by 48 hours.
In 4 hours exposure sites, over the first 72 hours after patch removal, all three treated sites exhibited very slight to well-defined erythema and/or very slight edema. The overall incidence and severity of irritation decreased gradually with time. All animals were free of dermal irritation by Day 7 (study termination).
The Primary Dermal Irritation Index for Dihydronepetalactone was 1.7.
Any other information on results incl. tables
INDIVIDUAL SKIN IRRITATION SCORES
3-MINUTE EXPOSURE
Animal No | Sex | Time after removal of patch | ||||
Minute | Hours | Days | ||||
30 - 60 | 24 | 48 | 72 | 7 | ||
3501 | F | 1/0 | 0/0 | 0/0 | 0/0 | 0/0 |
1-HOUR EXPOSURE
Animal No | Sex | Time after removal of patch | ||||
Minute | Hours | Days | ||||
30 - 60 | 24 | 48 | 72 | 7 | ||
3501 | F | 1/0 | 1/0 | 0/0 | 0/0 | 0/0 |
4-HOUR EXPOSURE
Animal No | Sex | Time after removal of patch | ||||
Minute | Hours | Days | ||||
30 - 60 | 24 | 48 | 72 | 7 | ||
3501 | F | 1/0 | 2/0 | 2/0 | 2/0 | 0/0 |
3502 | F | 1/0 | 2/0 | 1/0 | 1/0 | 0/0 |
3503 | F | 1/1 | 2/1 | 1/1 | 1/1 | 0/0 |
Total | 3/1 | 6/1 | 4/1 | 4/1 | 0/0 | |
Mean | 1.0/0.3 | 2.0/0.3 | 1.3/0.3 | 1.3/0.3 | 0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Mildly irritating according to GHS (8th revised edition)
- Executive summary:
A primary skin irritation test was conducted with rabbits to determine the potential for Dihydronepetalactone to produce irritation after a single topical application. Under the conditions of this study, the test substance is classified as slightly irritating to the skin.
Initially, one rabbit was tested to determine the irritation/corrosion potential of the test substance. Three dose sites, each approximately 6-cm2, were delineated on this animal. Five-tenths of a milliliter of the neat test substance was applied to the skin of each dose site. The pads and entire trunk of the animal were then wrapped with semi-occlusive 3-inch MicroporeTM tape to avoid dislocation of the patches. The patches were removed at the appropriate intervals (3 minutes, 1 hour, and 4 hours). All dose sites were evaluated for skin irritation according to the Draize method of scoring (Draize et al., 1944; see Table 6) and for corrosion 30-60 minutes after the appropriate patch removal. Subsequent evaluations were performed approximately 24, 48, 72 hours and at 7 days after removal of the 4-hour patch. Since there was no corrosion observed at any of the dose sites for this animal, two additional rabbits were selected for testing and had the test substance applied for 4 hours only. All dose sites were evaluated for skin irritation according to the Draize scoring system at 30-60 minutes, and 24, 48, 72 hours and at 7 days after patch removal.
No visible necrosis (corrosion) of the skin tissue was observed at the 3-minute, 1-hour and 4-hour dose sites during the study.
3-Minute Exposure Site: Within 30-60 minutes of patch removal, very slight erythema was noted at the 3-minute exposure site, which resolved by 24 hours.
1-Hour Exposure Site: Within 30-60 minutes of patch removal, very slight erythema was noted at the 1-hour exposure site. The overall incidence and severity of irritation decreased with time. Dermal irritation cleared from the treated site by 48 hours.
4-Hour Exposure Site: Over the first 72 hours after patch removal, all three treated sites exhibited very slight to well-defined erythema and/or very slight edema. The overall incidence and severity of irritation decreased gradually with time. All animals were free of dermal irritation by Day 7 (study termination).
The Primary Dermal Irritation Index (PDII) calculated for this test substance was 1.7. The test substance is Mildly irritating according to GHS (8th revised edition).
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