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Diss Factsheets

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non-GLP study performed according to a method similar to OECD Guideline 405. No individual animal data and no detailed doucmentation available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no individual animal data
Principles of method if other than guideline:
Method according to: Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-nitrobenzene
EC Number:
202-809-6
EC Name:
1-chloro-4-nitrobenzene
Cas Number:
100-00-5
Molecular formula:
C6H4ClNO2
IUPAC Name:
1-chloro-4-nitrobenzene
Details on test material:
- Name of test material (as cited in study report):
- Analytical purity: 99.3 % (techn. pure)

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 - 2,0 kg
- Housing: single
- Diet: ad libitum, Erka 8300, Robert Koch oHG, Hamm, Germany
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg (undissolved)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
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 according to Code of Federal Regulations, Title 16, Section 1500.42

TOOL USED TO ASSESS SCORE:
fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
other: irritation index
Basis:
mean
Time point:
other: 1h
Score:
6
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: highest irritation index after 1 hour
Irritant / corrosive response data:
Irritation index 6, maximum 110

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After 1 hour the test substance induced the highest irritation index of 6. Therefore no classification according to FDA guideline is required.
Executive summary:

Hoechst AG, 1977

The eye irritation potential of 1 -chloro-4 -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 other untreated eye served as control. 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 24, 48 and 72 hours after application.

After 1 hour the test substance induced the highest irritation index of 6. Therefore no classification according to FDA guideline is required.