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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
Study period:
13 to 20 April 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
other: Federal Register Vol 50 no 188, Part II, 27 September 1985
Version / remarks:
section 798-4500-Primary Eye Irritation
Principles of method if other than guideline:
A study was performed to determine the degree of ocular damage caused by the test chemical in rabbits
GLP compliance:
yes
Remarks:
report includes a statement by the study director and a QA statement

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material: 3-Pyrazolidinone, 4-methyl-1-phenyl-
- Molecular formula: C10H12N2O
- Molecular weight: 176.219 g/mole
- Smiles: O=C1NN(c2ccccc2)CC1C
- Inchl: InChI=1/C10H12N2O/c1-8-7-12(11-10(8)13)9-5-3-2-4-6-9/h2- 6,8H,7H2,1H3,(H,11,13)/f/h11H
- 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
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2-2.6 kg
- Housing: individually in metal cages with perforated floors
- Diet: SDS Standard Rabbit Diet ad libitum
- Water: tap water ad libitum
- Acclimation period: duration not indicated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): ca 19/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 mL (70 mg)
Duration of treatment / exposure:
NA
Observation period (in vivo):
after 1 hour and on day 1, 2, 3, 4 and 7
Number of animals or in vitro replicates:
3 males + 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Evaluation of the eyes over a period of 7 days did not show any signs of irritation

Any other information on results incl. tables

Animal no

1

2

3

1

24

48

72

4

7

1

24

48

72

4

7

1

24

48

72

4

7

 

cornea

0

0

0

0

0

0

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

0

0

0

0

0

0

 

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

1

0

0

0

0

0

1

0

0

0

0

0

1

0

0

0

0

0

 

chemosis

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Animal no

4

5

6

 

1

24

48

72

4

7

1

24

48

72

4

7

1

24

48

72

4

7

 

cornea

0

0

0

0

0

0

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

0

0

0

0

0

0

 

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

1

0

0

0

0

0

1

0

0

0

0

0

1

0

0

0

0

0

 

chemosis

1

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Evaluation of the eyes over a period of 7 days did not show any signs of irritation. The substance was not irritating to the eyes.
Executive summary:

In a study similar to OECD 405, 3 male and 3 female New Zealand White rabbits received 0.1 mL of the substance in the eye. Evaluation of the eyes over a period of 7 days did not show any signs of irritation. The substance was not irritating to the eyes.