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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 405 (Acute Eye 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
- Physical state: crystalline solid
- Analytical purity: no data

- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl bulk volume
Duration of treatment / exposure:
continuous
Observation period (in vivo):
1, 24, 48, and 72 h, and 8 days
Number of animals or in vitro replicates:
3
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
efflux
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0

Any other information on results incl. tables

No signs of eye irritation according to cornea and iris scores were observed throughout the test and observation period. One hour after application of the test substance, all animals showed slight conjunctival redness and swelling, as well as moderate efflux. These effects were fully reversible within 24 h.

Applicant's summary and conclusion

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

Schreiber (1982)

The eye irritation potential of 1,2 -dichloro-3 -nitrobenzene was investigated in 3 New Zealand White rabbits compliant with the OECD guideline 405 (adopted: 12 May 1981). A bulk volume of 0.1 mL of the crystalline test substance was applied into the conjunctival sac of the right eye of each animal, the left eye serving as control. The eyes were not rinsed after administration of the test substance. The eye irritation reactions were examined and scored using the Draize method 1, 24, 48 and 72 h as well as 8 days after application. 1,2-dichloro-3 -nitrobenzene induced slight conjunctival redness and swelling, as well as moderate efflux 1 h after administration. These effects were fully reversible within 24 h. The mean scores over 24, 48 and 72 h were 0.0 for corneal opacity and iritis in all animals (Schreiber, 1982).