Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Guideline study and GLP.

Data source

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

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:
1,3-dichloro-4-nitrobenzene
EC Number:
210-248-3
EC Name:
1,3-dichloro-4-nitrobenzene
Cas Number:
611-06-3
Molecular formula:
C6H3Cl2NO2
IUPAC Name:
1,3-dichloro-4-nitrobenzene
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance: other TS
TS-Freetext:
Reinheit: >99.5 %

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
With physiological saline moistened test substance was applied to the shaved skin and fixed with a plaster. After the 4 h exposure time the treatment area was rinsed with water observed for 72 hours and evaluated according to Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not irritating
Remarks on result:
other: not irritating
Irritant / corrosive response data:
the substance is evaluated to be non-irritating
Other effects:
-

Any other information on results incl. tables

Results:

 Time after patch removal        30 -60 min.        24 h        48 h        72 h
 Animal No:  1  2  3  1  2  3  1  2  3  1  2  3
 Formation of erythema and eschar  1  1  1  0  0  0  0  0  0  0  0  0
 Formation of edema  0  0  0  0  0  0  0  0  0  0  0  0

Applicant's summary and conclusion

Executive summary:

In a skin irritation/corrosion study in rabbits according to OECD TG 404 and GLP the animals were treated with 500 mg of test substance moistened with 0.18 ml isotonic saline for 4 hours. 30 -60 minutes after patch removal in all animals a very slight erythem could be observed. After 24 hours after patch removal in all animals no irritation symptoms could be observed any more.

The test substance was evaluated to be not irritating according to directive 83/467/EWG.

Categories Display