Registration Dossier

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: lack of details on test substance; observation period only 24 h instead of 72 h.
Principles of method if other than guideline:
Method: According to FDA, Fed.Reg.38, No.187, 1973:
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): o-Nitrochlorbenzol
- Analytical purity: no data
- Impurities (identity and concentrations): no data

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1,5 - 2 kg
- Diet: ERKA 8300, Robert Koch oHG, Hamm, Germany
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
other: undissolved test substance
Amount applied: 100 mg
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
24 hour(s)
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 hours of application

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 tested animals
Time point:
other: 24 hours
Score:
0
Max. score:
3
Remarks on result:
other: no readings performed at 48 and 72 h after instillation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 tested animals
Time point:
other: 24 hour
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 tested animals
Time point:
other: 1, 7, 24 hour(s)
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 tested animals
Time point:
other: 1, 7, 24 hour(s)
Score:
0
Max. score:
4

Any other information on results incl. tables

Eye irritation: Undissolved substance

Animal No.

Part of the eye

Observation time

1h

7h

24h

1

Cornea

Iris

Conjunctivae

Chemosis

0

0

2

0

0

0

0

0

0

0

0

0

2

Cornea

Iris

Conjunctivae

Chemosis

0

0

1

0

0

0

1

0

0

0

0

0

3

Cornea

Iris

Conjunctivae

Chemosis

0

0

1

0

0

0

0

0

0

0

0

0

4

Cornea

Iris

Conjunctivae

Chemosis

0

0

2

0

0

0

1

0

0

0

0

0

5

Cornea

Iris

Conjunctivae

Chemosis

0

0

1

0

0

0

0

0

0

0

0

0

6

Cornea

Iris

Conjunctivae

Chemosis

0

0

1

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Under these test conditions it can be assumed that no classification for 1-chloro-2-nitrobenzene is required because no irritating effects were observed after 24 hours. Criteria used for interpretation of results: EU
Executive summary:

Hoechst AG, 1975

The eye irritation potential of 1 -chloro-2 -nitrobenzene was investigated in 6 Himalyan rabbits according to the FDA guideline (federal register, Vol 38, No. 187, 1973). 100 mg undissolved test substance was applied into the conjunctival sac of one eye of each animal. The eyes were rinsed 24 hours after application of the test substance. The eye irritation reactions were examined and scored using the Draize method 1, 7 and 24h after application. After 1 hour 1 -chloro-2 -nitrobenzene induced slight conjunctival redness in all animals (4/6 score=1 and 2/6 score=2). These effects were reversible within 24 h. The mean scores at 24 h were 0.0 for corneal opacity, iritis, chemosis and conjunctivae in all animals. Therefore no classification according to EU classification criteria is required.