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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:
21 July 1987 to 24 July 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Remarks:
The study was conducted in accordance with quality assurance procedures.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 4-dimethylaminobenzoate
EC Number:
233-634-3
EC Name:
Ethyl 4-dimethylaminobenzoate
Cas Number:
10287-53-3
Molecular formula:
C11H15NO2
IUPAC Name:
ethyl 4-(dimethylamino)benzoate
Test material form:
other: crystalline/powdery solid
Details on test material:
- Appearance: White crystalline/powdery solid
- Storage conditions of test material: Ambient temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 to 13 weeks
- Weight at study initiation: 2.2 to 3.0 kg
- Housing: individually housed in metal cages with perforated floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Yes; the report states that all rabbits were acclimated to the laboratory environment

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30 to 70 % (relative)
- Air changes: Approximately 19 per hour
- Photoperiod:12 hours of artificial light in each 24 hour period (from 07.00 to 19.00 hours)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with 0.5 mL distilled water
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorso-lumbar region. Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers exposing an area of skin approximately 10 cm square.
- Coverage: 2.5 cm square; the test material was applied under a 2.5 cm square gauze pad
- Type of wrap if used: The test site was occluded with elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site washed with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- Examinations: Days 1 (30 minutes after patch removal), 2, 3 and 4

SCORING SYSTEM
- Erythema and Eschar Formation
0 = No erythema
1 = Very slight 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 the area well defined by definite raising)
3 = Moderate oedema (area raised approximately 1 mm)
4 = Severe oedema (area raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no response to treatment in any of the animals throughout the observation period. All scores for erythema and oedema were 0 for all animals at all time points.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study the test material was determined to be non-irritating to the skin.
Executive summary:

A study was performed to investigate the potential of the test material to cause skin irritation in accordance with the standardised guidelines OECD 404 and EU Method B.4.

Three New Zealand White rabbits were exposed to the test material in a semi-occlusive manner for 4 hours. The hair was clipped to expose skin on the dorso-lumbar region and 0.5 g of the test material was applied under a 2.5 cm² gauze pad, moistened with 0.5 mL of distilled water. The gauze pads were secured with an elastic adhesive dressing for a four-hour exposure period. After the four-hour exposure, the wraps were removed and the test sites were washed with water to remove any residual test material. The test sites were examined for dermal irritation at approximately 30 minutes and at 24, 48 and 72 hours following removal of the patches.

There were no signs of erythema or oedema during the course of the study. The mean erythema and oedema scores were 0.0 and 0.0, respectively. All rabbits scored 0 for both erythema and oedema at each evaluation.

Under the conditions of this study the test material was determined to be non-irritating to the skin.

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