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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)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity of test chemical and sex of test animals not reported
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
; purity of test chemical and sex of test animals not reported
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3,4-Dichloroanilin
- Physical state: solid, crystalline
- Analytical purity: no data
- Lot/batch No.: GEAC 40
- Storage condition of test material: 22°C, dark, under fume hood

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.9-4.0 kg
- Housing: individually in cages, individual ear tags
- Diet: ad libitum, Altromin 2123, 15 g Hay
- Water: ad libitum, deionized, clorinated water



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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: 0.1 mL polyethylenglycol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Lot/batch no. (if required): Ch-B 2322, Fa. Riedel de Haen AG
Duration of treatment / exposure:
4 h
Observation period:
0.5, 1, 24, 48, 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch, dorsal

- Type of wrap if used: non-irritating semiocclusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): luke warm water
- Time after start of exposure: 4 h


SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average over 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average over 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average over 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average over 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average over 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average over 24, 48 and 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

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

Hofmann, T and Weigand, W, 1986

The testing of 3,4 -dichloroaniline for dermal irritation/ corrosion on 3 New Zealand White rabbits according to OECD guideline 404/ EU B.4 did neither result in skin irritation or corrosion. Therefore 3,4 -dichloroaniline needs not to be classified.