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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To assess the ocular irritation potential of 4-nitro-m-phenylenediamine in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : 4-Nitro-m-phenylenediamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Smiles notation : c1(c(cc(N)cc1)N)[N+](=O)[O-]
- InChl (if other than submission substance): 1S/C6H7N3O2/c7-4-1-2-6(9(10)11)5(8)3-4/h1-3H,7-8H2
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material : 4-Nitro-m-phenylenediamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Smiles notation : c1(c(cc(N)cc1)N)[N+](=O)[O-]
- InChl (if other than submission substance): 1S/C6H7N3O2/c7-4-1-2-6(9(10)11)5(8)3-4/h1-3H,7-8H2
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Male
- Source: Hacking & Churchill ltd, Huntingdon, UK
- Age at study initiation: Not reported
- Weight at study initiation: average about 3 kg
- Housing: The animals were housed individually
- Diet (e.g. ad libitum): "muemmel Z-222" (Hoeing Kraftfutterwerk Lower Saxony, Verden / Aller), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 40-50%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle (artificial lighting. 7 - 19 h)

IN-LIFE DATES: From: To: Not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g of the solid test sample was applied by single injection in the conjunctival sac of an eyelid.
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
After application, the eyelids for about 1 sec were gently held together. The other eye remained untreated as a control. After 24 hours the treated eye was rinsed with physiological saline solution.

SCORING SYSTEM: As per the method of Draize
The sum of the weighted vote degrees in all animals at 24, 48 and 72 h (s, 4.1, a + b + c) was divided by the sum of the number of animals and observation time points (9) and yielded the-primary irritation score.

TOOL USED TO ASSESS SCORE: ophthalmoscope
The observations on the cornea after 24 hours was secured by application of 1 drop of 1% fluorescein solution in ophthalmic formulation and subsequent rinsing with saline solution under UV light.

Results and discussion

Results of in vivo study
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
9
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Of the controls differing findings were not charged. The animals were followed up until the 7th day of the experiment.Primary irritation score: 0/9

Any other information on results incl. tables

Table 1:Irritation Scores

Reading

1 hr

24 hr

48 hr

72 hr

Animal No.

18

19

10

18

19

10

18

19

10

18

19

10

CORNEA

A.   Degree of Opacity

0

0

0

0

0

0

0

0

0

0

0

0

B.   Area affected

0

0

0

0

0

0

0

0

0

0

0

0

a=AxBx5

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

IRIS

0

0

0

0

0

0

0

0

0

0

0

0

b=Ax5

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

CONJUNCTIVA 

A.     Redness

0

0

0

0

0

0

0

0

0

0

0

0

B.     Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

C.   

0

0

0

0

0

0

0

0

0

0

0

0

c=(A+B+C)x2

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

Total = a+b+c

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The primary eye irritation score for 4-nitro-m-phenylenediamine was determined to be 0.0 .
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be not irritating according to the E.C Commission's proposal on criteria for effects and irritants as set out in Annex VI II B 6 Directive.
Executive summary:

The primary eye irritation of 4-nitro-m-phenylenediamine was assessed in rabbits in a study conducted as per OECD Guideline 405.

0.1 g of the solid 4 -nitro-m-phenylenediamine was applied by single injection in the conjunctival sac of 3 male New Zealand White rabbits. The untreated eye served as a control. After 24 hours the treated eye was rinsed with physiological saline solution.The observations on the cornea after 24 hours were secured by application of 1 drop of 1% fluorescein solution in ophthalmic formulation and subsequent rinsing with saline solution under UV light. The animals were observed for signs of irritation at 1, 24, 48 and 72 hours. The animals were followed up until the 7th day of the experiment.

The reactions were scored as per Draize method.The sum of the weighted vote degrees in all animals at 24, 48 and 72 h (s, 4.1, a + b + c) was divided by the sum of the number of animals and observation time points (9) and yielded the-primary irritation score.

The primary eye irritation score of for 4-nitro-m-phenylenediamine was determined to be 0.0  . From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be not irritating according to the E.C Commission's proposal on criteria for effects and irritants as set out in Annex VI II B 6 Directive.