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Registration Dossier
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EC number: 203-161-7 | CAS number: 103-95-7
- 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:
- weight of evidence
- Study period:
- 1986-02-25 to 1986-03-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Test material applied semiocclusively to the skin of 4 rabbits for 4 hrs, at concentrations of 100% and 50 %. Skin reactions were reacorded after 1 hour, 24, 48, 72 hours and 7 days.
- GLP compliance:
- yes
- Remarks:
- no certificate
Test material
- Reference substance name:
- 3-p-cumenyl-2-methylpropionaldehyde
- EC Number:
- 203-161-7
- EC Name:
- 3-p-cumenyl-2-methylpropionaldehyde
- Cas Number:
- 103-95-7
- Molecular formula:
- C13H18O
- IUPAC Name:
- 2-methyl-3-[4-(propan-2-yl)phenyl]propanal
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Cyclamen aldehyde
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Refridgerated at 4 °C
- Other: Delivery date 1986-02-14
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A Smith, Warlingham, Surrey, United Kingdom
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually in anodised aluminium cages with grid floors and no bedding
- Diet: Ad libitum, rabbit pellets (680, Dalgety-Spillers Ltd)
- Water: Mains tap water, ad libitum.
- Acclimation period: ≥ 5 d.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 °C to 24 °C
- Humidity: 40 % - 67 %
- Air changes per hr: No data
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 100 % solution - no vehicle. 50 % solution DEP
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Volume applied: 0.5 mL:
- Concentration of test substance: 100 %, 50 % in DEP - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 7 d (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs and 7 d after removal of test material)
- Number of animals:
- 4 (each animal treated with both concentrations)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: Elastoplast elastic adhesive barrier, 10 cm width.
REMOVAL OF TEST SUBSTANCE
- Washing: Adhesive tapes removed, gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
- Erythema and eschar formation:
-- 0: No erythema
-- 1: Very slighty erythema (barely perceptible)
-- 2: Well-defined erythema
-- 3: Moderate to severe erythema
-- 4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Oedema formation:
-- 0: No oedema
-- 1: Very slight oedema (barely perceptible)
-- 2: Slight oedema (edges of area well defined by definite raising)
-- 3: Moderate oedema (raised approximately 1 mm)
-- 4: Severe oedema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 7 d.
- Remarks on result:
- other: 50% solution. Desquamation at 7 d.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: 50% solution. Marked desquamation at 7d.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 50% solution. Marked desquamation at 7 d.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 50% solution. Marked desquamation at 7 d.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: 50% solution
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: 50% solution
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: 50% solution
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 50% solution
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 100% solution. Marked desquamation at 7 d.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 100% solution. Marked desquamation at 7 d.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 100% solution. Marked desquamation at 7 d.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 7 d.
- Remarks on result:
- other: 100% solution. Marked desquamation at 7 d.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 7 d.
- Remarks on result:
- other: 100% solution
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 100% solution
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: 100% solution
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: 100% solution
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Of all animals
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Remarks on result:
- other: 100% solution
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Of all animals
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Remarks on result:
- other: 100% solution
- Other effects:
- Marked desquamation in rabbits 920, 922 and 923 at 7 d; desquamation in rabbit 916 at 7 d; no other comments.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Two concentrations of cyclamen aldehyde were tested. Classification is based on the study performed with 100%. The study was performed with more than 3 animals. In this case specific provisions apply to the classification criteria in CLP Regulation (EC) no. 1272/2008. In accordance with this classification criteria the test substance is considered to be a Category 2 skin irritant.
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