Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3-Dichloronitrobenzene
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: 2.7 kg
- Housing: single
- Diet (e.g. ad libitum): mümmel z (ssniff, Soest, Germany) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped skin
Vehicle:
other: oil (not further specified)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h, and 8 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0

Any other information on results incl. tables

Erythema/edema scores

 

Time point after patch removal

Animal No.

Sum

Average

1

2

3

 

 

Erythema score

1 h

0

0

0

 

 

24 h

0

0

0

0

0

48 h

0

0

0

0

0

72 h

0

0

0

0

0

8 days

0

0

0

 

 

Edema score

1 h

0

0

0

 

 

24 h

0

0

0

0

0

48 h

0

0

0

0

0

72 h

0

0

0

0

0

8 days

0

0

0

 

 

Applicant's summary and conclusion

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

Schreiber G (1982)

The skin irritation potential of 1,2 -dichloro-3 -nitrobenzene was evaluated according to the OECD guideline 404 (adopted: 12 May 1981). 0.5 g 1,2 -dichloro-3 -nitrobenzene ground in oil was applied to the clipped left flank of each of 3 New Zealand White rabbits for 4 h under semi-occlusive conditions. Thereafter patches and test material were removed. The test sites were examined and scored for erythema and edema using the Draize method 1, 24, 48 and 72 h as well as 8 days after exposure. The mean erythema and edema scores over 24, 48 and 72 h were 0.0 for both end points in all animals. No signs for skin irritation were observed throughout the test and observation period.