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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:
15 March 1994 - 25 March 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 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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2,4-dichlorophenyl)ethan-1-one
EC Number:
218-780-8
EC Name:
1-(2,4-dichlorophenyl)ethan-1-one
Cas Number:
2234-16-4
Molecular formula:
C8H6Cl2O
IUPAC Name:
1-(2,4-dichlorophenyl)ethan-1-one
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae. 88400 Biberach.
- Age at study initiation: About 3-5 months.
- Weight at study initiation: 2.6-2.7 kg
- Housing: In fully air-conditioned rooms, separate cages.
- Diet (e.g. ad libitum): Ad libium
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: PEG 400
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 0.5 g test item in 0.1 mL PEG 400 (5 g/mL)
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Application: Cellulose patch on a piece of surgical plaster.
- Type of wrap if used: Semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With warm tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30-60 minutes, 24, 48 and 72 hours after removal and after 7 days.

SCORING SYSTEM:
- Method of calculation: Eythema, eschar formation and oedema were evaluated numerically according to the technique of DRAIZE. All other changes of the skin were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
From 30 minutes up to 72 hours after removal of the patches one animal showed a very slight to well-defined erythema, which was fully reversible after 7 days. 30 minutes after removal all the patches a barely perceptible erythema was noted at the skin of another animal 24 hours p.a. the irritation was reversible. No irritation was observed at the skin of the 3rd animal.
Other effects:
- Other adverse local effects: No.
- Other adverse systemic effects: No.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined to be not irritating to the skin.
Executive summary:

An in-vivo skin irritation test was performed according to OECD Guideline 404 and EU Method B.4 (GLP study). About 24 hours before the start of the study the hair in the dorsal region of the body of 3 New Zealand White rabbits was removed with an electric clipper. Each animal was treated with 0.5 g test item pasted with 0.1 mL PEG 400. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and the covered with a semi-occlusive bandage. After 4 hour of exposure, all remmanents were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 -60 minutes, 24, 48 and 72 hours and 7 days after removal. Erythema and oedema were evaluated numerically according to the technique of DRAIZE. From 30 minutes up to 72 hours after removal of the patches one animal showed a very slight to well-defined erythema (24 -72h mean erythema score of 1.7 and oedema score of 0.0), which was fully reversible after 7 days. 30 minutes after removal all the patches a barely perceptible erythema was noted at the skin of another animal 24 hours p.a. the irritation was reversible (24 -72h mean erythema and oedema score of 0.0). No irritation was observed at the skin of the 3rd animal. Based on the results of this study, the test item was not irritating to the skin.

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