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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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
minors deviations (see below)
Principles of method if other than guideline:
The minor deviations were :
-the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol,
-on day 1, one animal had a body weight slightly lower than 2.2 kg,
-the animals were given 110 pelleted diet (instead of 112c pelleted diet).
These minor deviations were not considered to have compromised the validity or integrity of the study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
-Sex: male
- Age at study initiation: no data
- Weight at study initiation: 2.3 ± 0.2 kg.
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm)
- Diet (e.g. ad libitum): free access to 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
. temperature: 18 ± 3°C
. relative humidity: 30 to 70%
. light/dark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Number of animals:
3
Details on study design:
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined. Only animals with healthy intact skin were used.

ADMINISTRATION:
- Area of exposure: left flank (3-minute exposure) and right flank (4-hour exposure)
- Total quantity applied: 500 mg
- Administration frequency: once
- Removal of test substance: residual is wiped with a dry gauze patch
The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. The untreated skin served as control.

EXAMINATIONS:
- Scoring system: Draize's score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Neither erythema nor oedema were observed in the three rabbits at any exposure duration (3 minutes and 4 hours).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under these experimental conditions, the test substance DETU (DIETHYL THIOUREE) is non-irritant to skin when applied topically to rabbits.
Executive summary:

The potential of the test substance DETU (DIETHYL THIOUREE) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) guideline, and in compliance with the principles of Good Laboratory Practice Regulations.

In the first instance, the test substance was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not irritant on this first animal, it was then applied for 4 hours to two other animals.

A single dose of 500 mg of the test substance in its original form was applied to the closely­clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing.

Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.

No cutaneous reactions were observed during the study.

Mean scores over 24, 48 and 72 hours for each animal were 0.0 for erythema and oedema.

Under these experimental conditions, the test substance DETU (DIETHYL THIOUREE) is non-irritant when applied topically to rabbits.