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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
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.4
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-chloroaniline
- Physical state: yellow liquid
- Analytical purity: >99 %
- Lot/batch No.: October 1985
- Storage condition of test material: dark at room temperature under fume hood

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3-2,5 kg
- Housing: air-conditioned, individually, marked by ear tag
- Diet: ad libitum, altromin 2123, 15 g hay
- Water: ad libitum, tap water
- Acclimation period: in house

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:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

 time of patch removal  30 -60 min   24 h  48 h  72 h  7 d  14 d
 animal no.  1/2/3  1/2/3  1/2/3  1/2/3  1/2/3  1/2/3
 erythema score  1/1/1  2/2/2  1/2/2 1/1/1   1/1/1 0/0/0 
 edema score  0/0/0  1/1/1  0/0/1  0/0/0  0/0/0  0/0/0

Skin

 dry      x/x/x  x/x/x  x/x/x  x/x/x

 1/2/3
 scaling
     -/x/-  x/x/-  x/x/x  

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 for skin irritation and corrosion according to EU method B.4 on three New Zealand White resulted in slight irritations that did not fulfill the criteria for classification as irritating according to 83/467/EWG. Therefore o-chloroaniline was classified as not irritating.