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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
observation period 8 d
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-dichloro-3-nitrobenzene
EC Number:
221-717-7
EC Name:
1,2-dichloro-3-nitrobenzene
Cas Number:
3209-22-1
Molecular formula:
C6H3Cl2NO2
IUPAC Name:
1,2-dichloro-3-nitrobenzene
Details on test material:
- Analytical purity: No data

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:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24, 48 and 72 hrs
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at 24, 48 and 72 hrs
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at 24, 48 and 72 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24, 48 and 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: fully reversible
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: fully reversible
Irritation parameter:
conjunctivae score
Remarks:
efflux
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects

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

Executive summary:

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).