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Diss Factsheets

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:
17 March 1994 to 15 April 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-2-(4-chloro-2-methylphenoxy)propionic acid
EC Number:
240-539-0
EC Name:
(R)-2-(4-chloro-2-methylphenoxy)propionic acid
Cas Number:
16484-77-8
Molecular formula:
C10H11ClO3
IUPAC Name:
(R)-2-(4-chloro-2-methylphenoxy)propionic acid
Test material form:
solid: particulate/powder
Remarks:
Beige powder
Details on test material:
- Storage conditions: The test material was stored in a well-closed, light-resistant container, at room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: Rabbits were housed individually in plastic cages.
- Diet: Pelleted diet available ad libitum.
- Water: Tap water from the municipal water supply, filtered and softened was available ad libitum.
- Acclimation period: They were acclimatised to laboratory conditions for 26 days prior to treatment.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2 °C
- Humidity: 60 ± 15 °C
- Air changes: 15 air changes per hour (average, not monitored)
- Photoperiod: 12-hour light, 12-hour dark cycles

IN-LIFE DATES
- From: 17 March 1994
- To: 15 April 1994

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Clipped with electric clippers
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg of test material was applied to the right flank.

NEGATIVE CONTROL
- The left flank remained untreated and served as a control.
Duration of treatment / exposure:
The test material was held in contact with the skin for a period of 4 hours.
Observation period:
The study was terminated on Day 4
Number of animals:
Three female rabbits were selected for the study.
Details on study design:
TEST SITE
- Area of exposure: The day before treatment, the dorsum and the flanks of each animal were closely clipped with electric clippers. Only animals with healthy intact skin at the time of treatment were used. The test material was applied to an area of skin of 6 cm^2 on the right flank of the animals. Approximately 1 mL of 0.9 % saline was used to moisten the test material to ensure good contact with the skin. The left flank remained untreated and served as a control.
- Type of wrap if used: The test material was covered by a hydrophilic gauze patch which was secured by a semi-occlusive hypoallergenic dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The residual test material was gently removed with water.
- Time after start of exposure: At the end of the 4-hour period.

OBSERVATION TIME POINTS
Animals were checked for moribundity and mortality twice daily throughout the study. Animals were examined at least once daily for clinical signs. The cutaneous reactions were evaluated 1, 24, 48 and 72 hours after the removal of the dressings. As there were no signs of irritation after 72 hours, the study was terminated on Day 4.
At the end of the study period, animals were sacrificed without necropsy.

SCORING SYSTEM:
The skin reactions to treatment were evaluated according to the following 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 area well defined by definite raising)
3 = Moderate oedema (raised approximately 1 millimetre)
4 = Severe oedema (raised more than 1 millimetre and extending beyond the 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:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema and no oedema were observed at any time.
Other effects:
There were no mortalities during the study.
There were no clinical signs during the study.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to EU criteria.
Conclusions:
Under the conditions of this study, the test material did not produce positive criteria in any rabbit and was considered non-irritant to rabbit skin.
Executive summary:

The skin irritation potential of the test material was assessed in accordance with the standardised guideline OECD 404 under GLP conditions.

The potential of the test material to induce skin irritation/corrosion was assessed after a single semi-occlusive application for four hours in a group of three female rabbits. 500 mg of test material was applied to closely clipped skin. All animals were observed daily and the skin reactions were scored 1, 24, 48 and 72 hours after removal of the patches.

No erythema and no oedema were observed at any time. There were no mortalities during the study and no clinical signs.

Under the conditions of this study, the test material did not produce positive criteria in any rabbit and was considered non-irritant to rabbit skin.