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Diss Factsheets
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EC number: 942-438-3 | 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study following a method equivalent to a recognised OECD guideline. Deviations to recognised guideline are noted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive dressing smaller exposure area (ca. 2.5cm2), longer exposure period (24h) shorter observation period (48h)
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- Deviations:
- no
- Principles of method if other than guideline:
- The method was in accordance with the 16 CFR 1500.41 and US CPSC requirements
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of (1RS,3RS)-3-methyl-3-(4-methylpentyl)cyclohexyl acetate and (2RS,4aRS,8aSR)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate and (2RS,4aRS,8aRS)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate
- Molecular formula:
- not applicable (reaction mass of constitutional isomers)
- IUPAC Name:
- Reaction mass of (1RS,3RS)-3-methyl-3-(4-methylpentyl)cyclohexyl acetate and (2RS,4aRS,8aSR)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate and (2RS,4aRS,8aRS)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino; not otherwise specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Not reported.
- Weight at study initiation: Not reported.
- Housing: Not reported.
- Diet: rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped / abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): neat (liquid) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (sexes not specified)
- Details on study design:
- TEST SITE
- Area of exposure: According to 16 CFR 1500.41
- % coverage: Not reported. A group of six albino rabbits was clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
- Type of wrap if used: Occlusive (gauze wrapped with impervious material)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: Not applicable.
SCORING SYSTEM: Draize-scoring system. References: 16 CFR 1500.41 and 16 CFR 1500.3.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.12
- Max. score:
- 8
- Reversibility:
- no data
- Remarks on result:
- other: intact and abraded skin
- Irritant / corrosive response data:
- Intact skin: Very slight edema (barely perceptible) response in animal #3. Abraded skin: Very slight (barely perceptible) erythema and very slight edema (barely perceptible) was noted during the observation period in animal #3. All reactions fully reversed at 72 hours.
Any other information on results incl. tables
Table 1. Skin reactions (using Draize scoring method)
Erythema & Eschar Formation | Hours | Rabbit number | Mean score | |||||
1 | 2 | 3 | 4 | 5 | 6 | |||
Intact skin | 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | |
Abraded skin | 24 | 0 | 0 | 1 | 0 | 0 | 0 | 0.17 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | |
Edema | ||||||||
Intact skin | 24 | 0 | 0 | 1 | 0 | 0 | 0 | 0.17 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | |
Abraded skin | 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
72 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 | |
Sum of mean scores | 0.51 | |||||||
Primary irritation index = sum of mean scores/4 | 0.12 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Under the conditions of this study the test substance is not considered to be irritating to the skin.
- Executive summary:
The non-GLP study was completed under 16 CFR 1500.41 following a guideline similar to OECD 404, to assess the irritancy potential of the test material to the skin of the albino rabbit. The test substance was evaluated in 6 albino rabbits. A dose of 0.5 g test substance was applied to intact and abraded clipped dorsal skin site under a occlusive dressing for 24 hours. Skin observations were made 24 and 72 hours after patch removal. Very slight edema were noted at 24 hours in both intact and abraded skin in animal #3. Very slight erythema and edema were seen in abraded skin in animal #3. All other organisms gave negative responses. By 72 hours, all responses had fully reversed in both intact and abraded skin. The test material produced a mean primary irritation index (PII) of 0.12 and is considered to be non-irritating to skin.
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