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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:
From: 18/03/1986 To: 21/03/1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986
Reference Type:
secondary source
Title:
4-Nitrotoluene CAS 99-99-0
Author:
OECD SIDS
Year:
2003
Bibliographic source:
SIDS Initial Assessment Report for 17th SIAM, UNEP Publications

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
99-99-01
IUPAC Name:
99-99-01
Constituent 2
Chemical structure
Reference substance name:
4-nitrotoluene
EC Number:
202-808-0
EC Name:
4-nitrotoluene
Cas Number:
99-99-0
Molecular formula:
C7H7NO2
IUPAC Name:
1-methyl-4-nitrobenzene
Details on test material:
- Name of test material (as cited in study report): p-nitrotoluol
- Physical state: solid (yellow-green crystals)
- Analytical purity: 99%
- Storage condition of test material: in the dark at 22 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany. Conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.7-3.7 kg
- Housing: the animals were housed in individual cages in air conditioned room
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen (Altromin GmbH, Lage/Lippe, Germany) and hay as well
- Water (e.g. ad libitum): deionised and chlorinated water from automatic drinking trough

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3 °C
- Humidity (%):50+/-20 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 18/03/1986 To: 21/03/1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
Amount applied: 100 mg
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF THE TEST SUBSTANCE
Washing (if done): yes, with physiologic saline solution
- Time after start of exposure: at 24 hours after exposure, and at all the other time points. The washing was performed also when excretions were observed in the treate eyes and when the fluorescein test was performed on the cornea of the treated eyes.


SCORING SYSTEM: Draize Method


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritant / corrosive response data:
One hour post exposure all the animals presented a light and whit discharge. The conjunctiva was swollen in all the animals and showed a clear hyperaemia of the vasculature.
24 hours post exposure the animals showed still a clear hyperaemia of the vasculature up to carmine red coloration of the conjunctiva.
The effect described above were completely reversible within 48 hours.
One hour post exposure all the animals presented a light and whit discharge. The conjunctiva was swollen in all the animals and showed a clear hyperaemia of the vasculature.
24 hours post exposure the animals showed still a clear hyperaemia of the vasculature up to carmine red coloration of the conjunctiva.
The effects described above were completely reversible within 48 hours.

Any other information on results incl. tables















































































































Timeendpoint after application



24h



48h



72h


Average (24-72 h)animal 1 Average (24-72h) animal 2Average(24-72 h)animal 3  Total average 

Animal


number



1



2



3



1



2



3



1



2



3


1 2 3 -

Conjuctiva: Chemosis



0



0



0



0



0



0



0



0



0


0 0 0 0

Conjuctiva:


redness

1



2



1



0



0



0



0



0



0


 0.30.7  0.3 0.4

Iris



0



0



0



0



0



0



0



0



0


 0

Corneal


opacity



0



0



0



0



0



0



0



0



0


0 00

Fluoresceintest



0



0



0



 



 



 



0



0



0


    

 

Applicant's summary and conclusion

Executive summary:

Hofmann T (1986)


 


In a test according to OECD TG 405, 100 mg of 4-nitrotoluene was applied into the conjunctival sac of the left eye of each of three rabbits. 24 hours later the eyes were rinsed. One hour post exposure all the animals presented a light and whit discharge. The conjunctiva was swollen in all the animals and showed a clear hyperaemia of the vasculature.


 


24 hours post exposure the animals showed still a clear hyperaemia of the vasculature up to carmine red coloration of the conjunctiva.


 


The effects described above were completely reversible within 48 hours.


4-Nitrotoluene is not irritating to the eyes of rabbits.