4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted July 31, 1992

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

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.

Results 2

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.

Results 3

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.

Results 4

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.

Results 5

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.

Results 6

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.