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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:
1993-07-09 to 1994-02-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
EC 92/69
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Version / remarks:
1990
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MAFF no. 4200; 1985
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
416-600-4
EC Name:
-
Cas Number:
77703-56-1
Molecular formula:
C23H32N4O2
IUPAC Name:
3-butyl-1-[4-({4-[(butylcarbamoyl)amino]phenyl}methyl)phenyl]urea
Specific details on test material used for the study:
Analytical purity: >= 99.65 %
Lot/batch No.: 93.166

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: E.S.D. (Romans, 01400, Chatillon-sur-Chalaronne, FRANCE);
- Age at study initiation: about 3 months;
- Weight at study initiation: 2.00 to 3.00 kg
- Housing: individually in stainless steel cages;
- Diet: 150 g/animal/day; pelleted complete rabbit diet (Diet reference 112 C - Usine d'Alimentation Rationnelle, Villemoisson, 91360 Epinay-sur-Orge, FRANCE);
- Water: softened and filtered mains drinking water, ad libitum;
- Acclimation period: at least 5 days;


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3;
- Humidity (%): > 45 R.H. (target value);
- Air changes (per hr): minimum 12 air changes,;
- Photoperiod: 12 hours artificial light/12 hours dark;

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
46 mg
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
The test article was reduced to a fine powder and administered without rinsing and at the dose level of 46 mg (quantity corresponding to a volume of 0.1 mL) per animal, into the inferior conjunctival sac of the right eye of 6 New Zealand White male rabbits.
The ocular examinations were performed in the conjunctiva, iris and cornea, according to a numerical scale, 1 hour after administration of the test article, then at 24, 48 and 72 hours.
Mean values were calculated from the evaluation of the ocular lesions performed in all the rabbits examined at 24, 48 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Mean values for ocular irritation were as follows:
global average ( 24 + 48 +7 2 h):
- 0.17 for chemosis to conjunctiva,
- 0.11 for enanthema to conjunctiva;
- 0.06 for congestion to iris;
- 0.00 for opacity to cornea;
Further information: see Sect. "Remarks on results incl. tables and figures"
Other effects:
None

Any other information on results incl. tables

Test article: 

PATE HAT Application: 46 mg (quantity corresponding to a volume of 0.1 mL) per animal of the test article reduced to a fine powder, without rinsing.   

  

Readings

Rabbits N°

Conjunctiva

Iris

Cornea

Chemosis

Enanthema

Reflex (+)

Congestion

Opacity

Ulceration

Degree

Area

1 H

63677

0

1

N

0i

0

0

0

63679

1

1

N

1i

0

0

0

63685

1

1

N

1i

0

0

0

63687

1

2

N

1i

0

0

0

63694

1

1

N

1c

0

0

0

63698

0

1

N

1c

0

0

0

24 H

63677

0

0

N

0i

0

0

0

63679

1

0

N

0

0

0

0

63685

1

1

N

0i

0

0

0

63687

0

0

N

0

0

0

0

63694

0

0

N

0

0

0

0

63698

0

1

N

1i

0

0

0

Means

0.33

0.33

 

0.17

0.00

 

 

48 H

63677

0

0

N

0

0

0

0

63679

0

0

N

0

0

0

0

63685

1

0

N

0i

0

0

0

63687

0

0

N

0

0

0

0

63694

0

0

N

0

0

0

0

63698

0

0

N

0i

0

0

0

Means

0.17

0.00

 

0.00

0.00

 

 

72 H

63677

0

0

N

0

0

0

0

63679

0

0

N

0

0

0

0

63685

0

0

N

0

0

0

0

63687

0

0

N

0

0

0

0

63694

0

0

N

0

0

0

0

63698

0

0

N

0

0

0

0

Means

0.00

0.00

 

0.00

0.00

 

 

MEANS

24 H + 48 H +72 H

0.17

0.11

 

0.06

0.00

 

 

(+) : N = Normal – R = Reduced – 0 = No reflex

 

OBSERVATIONS:

c: Circumcorneal injections + congestion of the iris. 

i: Circumcorneal injections.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
HAT ISO was tested for acute ocular irritation and reversibility in rabbits. From the results obtained under the experimental conditions employed, application of this test article to the rabbit's eye provoked a slight irritation. The observed signs were fully reversible within 3 days. No classification and labelling for eye irritation is necessary according to Regulation 1272/2008/EC (CLP).
Executive summary:

HAT ISO was tested for acute ocular irritation and reversibility in rabbits. From the results obtained under the experimental conditions employed, application of this test article to the rabbit's eye provoked a slight irritation. The observed signs were fully reversible within 3 days. No classification as an eye irritant is necessary.