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EC number: 205-271-0 | CAS number: 136-99-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.11.21 to 2000.12.01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted July 31, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted July 31, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
- EC Number:
- 205-271-0
- EC Name:
- 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
- Cas Number:
- 136-99-2
- Molecular formula:
- C16H32N2O
- IUPAC Name:
- 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol
- Test material form:
- solid: crystalline
- Details on test material:
- - State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles:
- Crystal structure:
- Coating:
- Surface properties:
- Density:
- Moisture content:
- Residual solvent:
- Activation:
- Stabilisation:
- Other:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in a cool, dry and well ventilated place and away from foodstuffs. In darkness at room temperature.
- Stability under test conditions: Yes
- Solubility and stability of the test substance in the solvent/vehicle: Slighthly soluble in water 33.9 mg/L
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Reacts with strong acids
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Remark: Environmental precautions: Do not allow to enter drains or waterways.
Do not discharge into the subsoil/soil
Constituent 1
- Specific details on test material used for the study:
- Test material information:
2-(2-undecyl-4,5-dihydro-1H-imidazol-1-yl)ethanol
Specific details on test material used for the study:
name: Lauryl-hydroxyethylthylimidazoline
CAS-Number: 136-99-2
Content >85%
Appearance: white solid
Storage conditions: darkness at approximately 20°C In a fume
Impurities (identity and concentrations):
Composition of test material, percentage of components: >85%
Lot/batch No.: Batch 1
Expiration date of the lot/batch: August 29, 2002
Stability and homogeneneity in the vehicle: is guaranteed for 1 hour
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 86353 Kißiegg
- Age at study initiation: NA
- Weight at study initiation: 2.3-2.8 kg
- Housing:
- Diet (e.g. ad libitum): Ssniff® K-H (V2333) ad libitum and hay (approx 15 g daily)
- Water (e.g. ad libitum): ad Libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): RT 20± 3°C
- Humidity (%): : Relative humidity 50± 20%
- Air changes (per hr): NA
- Photoperiod (hrs dark / hrs light): 12 hours daily
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 0.3 mL of sesame oil
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mG
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):0.3 mL
- Lot/batch no. (if required): no required
- Purity: - Duration of treatment / exposure:
- 3 min and 4 Hour
- Observation period:
- 30, 60 minutes and 24 hours (treatment 4 hours)
30, 60 minutes and 24, 48 and 72 hour (treatment 3 minutes) - Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm2
- % coverage:
- Type of wrap if used: cellulose patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
- Time after start of exposure: 3 minutes and 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
30-60 minutes as well as 24, 48, 72 hours after removal of the patche
SCORING SYSTEM:
- Method of calculation: DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Animal 107
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the marked irritations of the skin the animals were killed at day two of the study.
- Irritation parameter:
- erythema score
- Remarks:
- Animal 108
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the marked irritations of the skin the animals were killed at day two of the study.
- Irritation parameter:
- erythema score
- Remarks:
- Animal 109
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the marked irritations of the skin the animals were killed at day two of the study.
- Irritation parameter:
- edema score
- Remarks:
- Animal 107
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the marked irritations of the skin the animals were killed at day two of the study.
- Irritation parameter:
- edema score
- Remarks:
- Animal 108
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the marked irritations of the skin the animals were killed at day two of the study.
- Irritation parameter:
- edema score
- Remarks:
- Animal 109
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to the marked irritations of the skin the animals were killed at day two of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Based on the results of this study 2-(2-undecyl-4,5-dihydro-1H-imidazol-1-yl)ethanol is corrosive to skin.
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