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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Ûberprüfung der durchführbarkeit von Prüfungsvorschriften und der Aussagekraft der Grundprüfung des E. Chem. G.
Author:
Korte F and Greim H
Year:
1981
Bibliographic source:
Umweltforschungsplan des Umweltministeriums des Innern, Chemikalien, Forschungsbericht 107 04 006/01. 172
Reference Type:
secondary source
Title:
European Union Risk Assessment Report - 1,2,4-Trichlorobenzene
Author:
European Commission - European Chemicals Bureau
Year:
2003
Bibliographic source:
Office for Official Publications of the European Communities

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Acclimation period not reported, detailed test results are not available
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,4-trichlorobenzene
- Analytical purity: 98%

Test animals

Species:
rabbit
Strain:
other: White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5-2.8 kg
- Housing: V2A-Steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 60 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light



Test system

Type of coverage:
other: see "details on study design"
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
14 days. With the persistence of skin damage the examination period was extended until full recovery.
Number of animals:
6
Details on study design:
TEST SITE
In order to test the skin compatibility to 1,2,4-trichlorobenzene, the patch-test procedure was performed. 0.5 g of the test substance was applied on an approximately 6 cm² linen patch. The linen patch was covered with an equally large plastic film by means of a rubberized bandage (Leukoplast, P. BEIERSDORF AG & CO., Unna Straße 48, D-2000 Hamburg) and attached on the shaved skin of the back of the animals between the front and hind limbs. The linen patch stayed 4 hours on the skin. During this time the animals were kept in a rabbit-case, where although some freedom of movement was allowed, a rotation of the whole body was not possible. The head of the animals was not fixed in a special way.

SCORING SYSTEM: Draize score. For further details see "Any other information on materials and method incl. tables"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 min, 24, 48, 72, and 96 hours, 7 and 14 days
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 min, 24, 48, 72, and 96 hours, 7 and 14 days
Score:
1
Max. score:
4
Irritant / corrosive response data:
1,2,4-trichlorobenzene caused slight redness and slight oedema

Any other information on results incl. tables

Detailed results are not available

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Korte & Greim (1981):

In order to test the skin compatibility to 1,2,4-trichlorobenzene, a the patch-test procedure was performed according to OECD guideline 404 with deviations (Analytical purity and acclimation period not reported, detailed test results are not available).

5 g of the test substance was applied on an approximately 6 cm² linen patch.

Detailed test results are not available. However the test substance substance caused slight redness and slight oedema. Thus no classification is indicated according to the EU classification criteria for effects after a single exposure.