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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP condition

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
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.4
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-dichloroaniline
EC Number:
209-057-8
EC Name:
2,4-dichloroaniline
Cas Number:
554-00-7
Molecular formula:
C6H5Cl2N
IUPAC Name:
2,4-dichloroaniline
Test material form:
other: brown-red flakes
Details on test material:
- Name of test material (as cited in study report): 2,4-dichloroaniline
- Physical state: solid (brawn-red flakes)
- Analytical purity: 99%
- Impurities (identity): 2,6-dichloroaniline, monochloroaniline (p-chloroaniline)
- Storage condition of test material: in the dark at 22°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2-2.6 kg
- Housing: individually
- Diet ad libitum:
- Water ad libitu,:
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylenglycol 400
Controls:
other: the untreated skin served as control
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
4 hours
Observation period:
after the application period: 30-60 minutes, 24, 48, and 72 hours, and 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Test substance was moistened with polyethylene glycol and a pplied to the shaved skin
- Area of exposure: 25 cm²
- Type of wrap: 2.5 x 2.5 cm cellulose layer on the prepared skin site was fixed wtíth plaster; the total area was covered by a semiocclusive bandage.
- exposure time: 4 h

REMOVAL OF TEST SUBSTANCE
- Washing yes, carefully with lukewarm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: overall erythema score
Basis:
mean
Time point:
other: total observation period
Score:
0.8
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: overall edema score
Basis:
mean
Time point:
other: total observation period
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Thus, the test ssubstance causes minimal effects which do not lead to classification

Applicant's summary and conclusion

Interpretation of results:
not irritating
Executive summary:

2,4 -Dichloroaniline was tested for irritating potential according to OECD TG 404 under GLP conditions. 500 mg test substance per animal was moistened with polyethylene glycol 400 and applied to a shaved area of each of 3 rabbits which was covered by semi-occlusive dressing for 4 hours. Afterwards the area was washed carefully with lucewarm water and regularily observed for up to 7 days. The treated area showed very slight redness (mean score: 0.8) and very slight edema (mean score 0.1) which disappeared within the 7 day observation period. These slight effects do not lead to classification or labelling.