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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-04-08 to 1986-04-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD and GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981-05-12
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dihydro-5-nitro-2H-benzimidazol-2-one
EC Number:
202-282-2
EC Name:
1,3-dihydro-5-nitro-2H-benzimidazol-2-one
Cas Number:
93-84-5
Molecular formula:
C7H5N3O3
IUPAC Name:
5-nitro-1,3-dihydro-2H-benzimidazol-2-one

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Hoechst AG, Kastengrund, conventional breed
- No of animals: 3
- Labeling: numbered ear tag
- Weight: 2.5-3.7 kg
- Age: 3-5 months
- Air conditioned rooms, single cages
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Feed: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum, as well as about 15 g of hay per day
- Water: deionized, chlorinated water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye of each animal served as control
Amount / concentration applied:
- Amount applied: 100 mg Nitrolon
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.7
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.7
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hrs
Score:
0.7
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
other: Fluorescein-test
Basis:
animal #1
Time point:
other: 24 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: brightening area under UV and fluorescein
Irritation parameter:
other: Fluorescein-test
Basis:
animal #2
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: brightening area under UV and fluorescein
Irritation parameter:
other: Fluorescein-test
Basis:
animal #3
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: brightening area under UV and fluorescein
Other effects:
- one hour up to 24 hrs: swollen conjunctiva, hyperemia of blood vessels
- clear (due to test substance slightly yellowish) discharge

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In conclusion the test for eye irritation revealed that the test item is not an eye irritant following the mentioned guidelines and directives.
Executive summary:

The test substance Nitrolon was tested on new zealand albino rabbit for its potency as an eye irritance in accordance with OECD test guideline 405, adopted 1981 -06 -12 and following EU-Guideline B.5 in directive 84/448/EEC. For the classification directive 83/467/EEC was considered.

The substance was tested without a vehicle on one eye, the counterside eye served as internal control. During the observation period the animals were examined in intervalls for clinical signs at 1 - 24 - 48 - 72 hours. All symptoms disappeared after latest 72 hours, no severe symptoms could be recorded.

In conclusion the test for eye irritation revealed that the test item is not an eye irritant following the mentioned guidelines and directives.