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EC number: 265-747-9 | CAS number: 65405-84-7
- 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:
- 24.08 - 20.09.2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to guideline under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- α,2,2,6-tetramethylcyclohexene-1-butyraldehyde
- EC Number:
- 265-747-9
- EC Name:
- α,2,2,6-tetramethylcyclohexene-1-butyraldehyde
- Cas Number:
- 65405-84-7
- Molecular formula:
- C14H24O
- IUPAC Name:
- 2-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)butanal
- Details on test material:
- - Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature (range 20°C +- 5°C), light protected, under nitrogen
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 12 - 13 weeks (male), 9 - I I weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-1 5
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with electric clipper
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of Dihydro-C14-Aldehyde was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm
- Concentration (if solution): pure
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- viability/mortality: Daily from acclimatization of the animals to the termination of test
cinical signs: daily from acclimatization of the animals to the termination of test
body weights: at start of acclimatization, on the day of application and at termination of observation - Number of animals:
- 3 animals
1 male and 2 female - Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the
Commission Directive 2004/73/EC, April 29, 2004
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- animal #25, male
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- animal #26, female
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- animal #27, female
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- animal #25, male
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- animal #26, female
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- animal #27, female
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- See remarks on results
- Other effects:
- No other effects
Any other information on results incl. tables
Skin irritation scores - individual mean values after 24, 48 and 72 hours:
animal number | sex | erythema | N | oedema | N |
25 | M | 1.33 | 3 | 0.33 | 3 |
26 | F | 2.67 | 3 | 2.00 | 3 |
27 | F | 1.33 | 3 | 0.67 | 3 |
N = number of available data points
Skin irritation scores - assessment according to EEC guidelines
evaluated intervals | erythema | oedema |
24 hours | not irritating | not irritating |
48 hours | ||
72 hours |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59EC of August 2001), Dihydro-C14-Aldehyde is considered to be
"not irritating" to rabbit skin - Executive summary:
The primary skin irritation potential of Dihydro-C14 -aldehyde was investigated according to OECD test guideline no. 404. The test was applied by topical semi-occlusive application of 0.5 ml to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, seperately. The mean erythema/eschar score of the three animals was 1.33, 2.67 and 1.33, respectively and the mean oedema score was 0.33, 2.00 and 0.67, respectively.
The application of Dihydro-C14 -aldehyde to the skin resulted in mild to moderate, earlyonset and transient signs of irritation such as erythema, oedema and scaling. These effects were reversible and were no longer evident 14 days after tretment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Based upon the referred classification criteria (Commission Directive 2001/59EC of August 2001), Dihydro-C14-Aldehyde is
considered to be "not irritating" to rabbit skin.
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