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Toxicological information

Skin irritation / corrosion

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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:
2000
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

Constituent 1
Chemical structure
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
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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