Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
from to 16-6-1992 until 30-06-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dichloroaniline
EC Number:
210-157-9
EC Name:
2,3-dichloroaniline
Cas Number:
608-27-5
Molecular formula:
C6H5Cl2N
IUPAC Name:
2,3-dichloroaniline
Details on test material:
- Name of test material (as cited in study report): 2,3-dichloroaniline pure
- Physical state: liquid
- Analytical purity: 99.5%
- Lot/batch No.: 1
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: refrigerator

Test animals

Species:
rabbit
Strain:
other: HC:NZW

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: none
Controls:
other: Skin area not treated with test substance served as control
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
24, 48, and 72 hours
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 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 and 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 and 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 7 and 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: within 7 days
Other effects:
Eschar formation occurred in all rabbits on exposed skin up to 14 days post exposure;
skin was fissured in all 3 rabbits on day 1, 2, and 7 which proved to be reversible within 14 days; skin was hardened on day 7 in 1/3 rabbits -whitish squamous coat on the skin in all 3 rabbits on day 14

Applicant's summary and conclusion