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EC number: 248-093-9 | CAS number: 26896-20-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline (404): GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): MRD-91-947
- Physical state: colorless liquid
- Analytical purity: assumed 100%
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products.
- Age at study initiation: males (17-19 weeks), females (16-18 weeks)
- Weight at study initiation: 2.7 – 3.16 kg
- Housing: individually
- Diet (e.g. ad libitum): Agway certified diet R.C.A. rabbit – ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): assumed 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 45 minutes, 24h, 48h, 72h, and 7 days post patch removal
- Number of animals:
- 6 (2 male, 4 female)
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water and paper towel
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 through 72 hours
- Score:
- 0.67
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 through 72 h
- Score:
- 0.72
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 through 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritant / corrosive response data:
- Topical application elicited very slight erythema in one animal at the 45 minute interval. Erythema increased after the 45 minute interval. At the 24 hour interval, one animal was noted with well-defined erythema and two animals were noted with very slight erythema. At the 48 hour interval, one animal was noted with well-defined erythema and three animals with very slight erythema. Four animals were noted with very slight erythema at the 71 hour interval. Erythema decreased at the Day 7 interval; one animal was noted with very slight erythema. Edema was not noted at any observation point. Desquamation was noted for three animals at the Day 7 interval.
- Other effects:
- There were no animal deaths.
Any other information on results incl. tables
Individual Dermal Scores | ||||||
45 min | 24 H | 48 H | 72 H | Day 7 | ||
Animal #1 (M) | erythema | 0 | 0 | 0 | 0 | 0 |
edema | 0 | 0 | 0 | 0 | 0 | |
Animal #2 (M) | erythema | 0 | 0 | 1 | 1 | 0 |
edema | 0 | 0 | 0 | 0 | 0 | |
Animal #3 (M) | erythema | 1 | 1 | 1 | 1 | 0 |
edema | 0 | 0 | 0 | 0 | 0 | |
Animal #4 (F) | erythema | 0 | 2 | 2 | 1 | 1 |
edema | 0 | 0 | 0 | 0 | 0 | |
Animal #5 (F) | erythema | 0 | 0 | 0 | 0 | 0 |
edema | 0 | 0 | 0 | 0 | 0 | |
Animal #6 (F) | erythema | 0 | 1 | 1 | 1 | 0 |
edema | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The skin irritation potential for neodecanoic acid is minimal.
- Executive summary:
Neodecanoic acid was administered via an occluded dermal patch to 6 rabbits at a dose of 0.5 ml neat solution for 4 hours to assess the skin irritation potential. Dermal evaluations occurred at 45 minutes, 24h, 48h, 72h, and 7 days post patch removal. Application sites were graded for erythema, edema, and other signs of dermal irritation according to the Draize method of scoring. Topical application elicited very slight erythema in one animal at the 45 minute interval. Erythema increased after the 45 minute interval. At the 24 hour interval, one animal was noted with well-defined erythema and two animals were noted with very slight erythema. At the 48 hour interval, one animal was noted with well-defined erythema and three animals with very slight erythema. Four animals were noted with very slight erythema at the 71 hour interval. Erythema decreased at the Day 7 interval; one animal was noted with very slight erythema. Edema was not noted at any observation point. Desquamation was noted for three animals at the Day 7 interval. The mean skin irritation scores between 24 and 72 hours were: erythema 0.72 and edema 0.
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