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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Content: > 99 %
Colour: colourless
State of matter: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Average weight at study initiation: 2.1 – 2.5 kg

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Photoperiod: 12 h dark, 12 h light
- Housing: one animal per cage
- Diet: "Altromin 2123" ad libitum and 15 g hay per day
- Water: deionized and chlorinated water (ad libitum)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL 3,4-dichlorotoluene (pur).
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- the skin was shaved 24 h bevore test. Only animals with unimpaired skin were used.
- Area of exposure: 2.5 x 2.5 cm.
- Coverage: plaster with a layer of cellulose, covered with a semioclusive bandage.

After 4 hours of exposure the skin was washed with water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Average of 24 h, 48 h, 72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Average of 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Conclusions:
3,4-Dichlorotoluene is classified (67/548/EEC) as non-irritant.
Executive summary:

In a dermal irritation study (Hoechst AG, 1986) 3 New Zealand White rabbits were dermally exposed to 3,4-dichlorotoluene (pure). The test site (intact, shaved skin) was covered with a plaster with a layer of cellulose for 4 hours. The skin then was washed with water. Rabbits were observed for 14 days. Irritations regarding erythema and edema were scored after 30-60 min, 24 hours, 48 hours, 72 hours, 7 days and 14 days.

The test results lead to a classification according to OECD Guideline 404: non-irritant.