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Diss Factsheets
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EC number: 245-846-3 | CAS number: 23727-15-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 May 1998 to 25 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP compliant study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
- EC Number:
- 224-815-8
- EC Name:
- (R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
- Cas Number:
- 4501-58-0
- Molecular formula:
- C10H16O
- IUPAC Name:
- (1R)-(2,2,3-trimethylcyclopent-3-ene-1-yl)acetaldehyde
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): ALDEHYDE CAMPHOLENIQUE DROIT
- Physical state: colourless liquid
- Storage condition of test material: at room temperature away from light and heat
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: JEGARD, 22120 Yffniac, France
- Weight at study initiation: average weight 2.8 kg
- Diet : complete pelleted rabbit maintenance diet ERGILAP Anco, COFNA (37000 Tours, France)
- Housing: Individual housing on floor grid
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- in accordance with the requirements of 86/609/EEC guideline
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/rabbit - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days after patch removal
- Number of animals:
- Three - two males and one female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze held in place with 5 x 5 cm 'Micropore' fastening tape.
- Type of wrap if used: 10 cm wide stretch tape fastened around the trunk by adhesive tape of the same width.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed using cotton wool moistened with distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The skin was observed at 1, 24, 48 and 72 hours and extended no more than 14 days to establish reversibility. Any irritation was scored using the numerical scale below:
Erythema and eschar formation
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema 4
Oedema formation
No oedema 0
Very slight oedema 1
Slight oedema 2
Moderate oedema 3
Severe oedema 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: day eight for two animals; very slight erythema seen in one animal at the end of the observation period
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day eight for two animals; very slight erythema seen in one animal at the end of the observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- One hour after patch removal, very slight to well defined erythema (scores 1 and 2) and moderate to severe oedema (scores 3 and 4) were seen in all animals. During the following 72 hours of the test, erythema reactions increased in two animals but decreased in one and oedema reactions decreased in all animals.
The reversibility of these reactions was complete for two animals 6 and 8 days after treatment. The remaining animal still had very slight erythema at the end of the observation period. - Other effects:
- Structural modifications were observed between days 2 and 3; a cutaneous thickening associated with a dryness of the skin in all animals and a slight loss of skin in one animal.
Any other information on results incl. tables
Table 1: Individual values of skin reactions
Scores | Mean scores | Scores | |||||
Animal number | 1 hour (D1) | 24 hours | 48 hours | 72 hours | over 24-72h | D5 | D6 |
Erythema | |||||||
7255 | 1 | 2 | 2 | 2 | 2.0 | 2 | 2 |
7270 | 1 | 2 | 2 | 2 | 2.0 | 2 | 1 |
7278 | 2 | 2 | 2 | 1 | 1.7 | 1 | 1 |
Oedema | |||||||
7255 | 4 | 3 | 3 | 3 | 3.0 | 2 | 2 |
7270 | 3 | 3 | 2 | 2 | 2.3 | 2 | 2 |
7278 | 3 | 3 | 2 | 1 | 2.0 | 1 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test substance was determined to be a skin irritant.
- Executive summary:
In a GLP compliant skin irritation study conducted in line with standardised guideline OECD 404, the skin irritancy of the test substance was determined. Under the conditions of the test, following application of the test substance for four hours under a semi-occlusive patch, very slight to well defined erythema and moderate to severe oedema was seen in all animals. During the following 72 hours, erythema reactions increased in two animals but decreased in one and oedema reactions decreased in all animals. The reversibility of these reactions was complete for two animals 6 and 8 days after treatment and the remaining animal still had very slight erythema at the end of the observation period. The test substance is considered to be a skin irritant.
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