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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:
4 October 1983 to 7 October 1983
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP statement dates to Dec 18, 1987 Study report dates to Oct 14, 1983

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
EC Number:
617-441-5
Cas Number:
83121-18-0
Molecular formula:
C14 H6 Cl2 F4 N2 O2
IUPAC Name:
1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.3-2.4 kg
- Housing: The animals were caged individually in stainless steel cages
- Diet: ad libitum, pelleted standard Kliba 341, rabbit maintenance diet
- Water: ad libitum, tap water
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of the moistened (tap water) test substance

Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: on the dorsum of each rabbit
- Test patch approximately 3.0 cm x 3.0 cm
- Type of wrap: impermeable material and fastened to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h (at the end of the exposure period)

OBSERVATION TIME POINTS
The skin reaction of the treated skin site was observed 1 hour, 24, 48, 72 hours following removal of bandages and gauze patch.

SCORING SYSTEM:
A numerical scoring system according to Draize J.H. 1959 was used to grade the skin lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: #32
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: #32
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: #33
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: #33
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: #34
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: #34
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:
mean
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:
mean
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:
The test substance showed a primary irritation index of 0 when applied to intact rabbit skin.
No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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