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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:
January 2nd 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No information on the purity of the substance provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Dated February 24th 1987
Deviations:
yes
Remarks:
Purity of test substance unknows. No analysis certificate available
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-1-phenyl-5-pyrazolone
EC Number:
201-891-0
EC Name:
3-methyl-1-phenyl-5-pyrazolone
Cas Number:
89-25-8
Molecular formula:
C10H10N2O
IUPAC Name:
5-methyl-2-phenyl-2,3-dihydro-1H-pyrazol-3-one
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 503 0025
- Expiration date of the lot/batch: not specified
- Purity test date: no data
- Asect : white powder

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Final preparation of a solid: no preparation

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: not specified
- Weight at study initiation: 2.2 to 3.5 kg
- Housing:Individually in polystyrene or stainless steel cage
- Diet (e.g. ad libitum): Pellet diet 112C (U.A.R., France).Analysis was made (composition and contaminants) for each batch by the supplier. Moreover, this analysis were periodically made by CIT.
- Water (e.g. ad libitum): Drinking water filtered by 0.22 micron membran (F.G. Millipore) was delivered by bottle. Bacteriological, chemicals analysis and detection of the major contaminants (pesticides, heavy metals and nitrosamines) were periodically made.
- Acclimation period: at least 5 days before instillation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3C
- Humidity (%): 30% to 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h of light / 12h of dark

IN-LIFE DATES: From: To: Not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye that did not received any product served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
one hour, 24h, 48h and 72 h after instillations
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed after instillation of the test substances
- Time after start of exposure: 24h after instillation

SCORING SYSTEM:
based : -on Cornea ulceration and opacity (score 4 for opaque cornea to 0 for no ulceration and opacity) and opacity area (4 for three quarters to 1 for one quarter)
- Iris hemorrhage, reaction to light, swelling (score 2 for hemorrhage, gross destruction or no reaction to light, to 0 normal iris)
- Conjunctivae redness (score 3 for diffuse beefy red to 0 for normal), chemosis lids and/or nictating membranes swelling (score 4 for swellingh with lids more than half closed, to 0 normal)
-Discharge (score 2 for Discharge with moistening of lids and hairs adjacent to
lids, to 0 for absence of discharge)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
other: 1 hour
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 hour
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: Redness score
Basis:
animal #3
Time point:
other: 1 hour
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular reactions were observed in all animals.

Any other information on results incl. tables

Rabbit identification

EyesArea

Ocularreactionsdescription

Scores

Irritation score

Interpretation(+) (-)

1h

24h

48h

72h

01

Conjunctiva

Chemosis

0

0

0

0

0.0

(-)

Redness

0

0

0

0

0.0

(-)

Discharge

2

0

0

0

0.0

 

Iris

0

0

0

0

0.0

(-)

Corneaopacity

Degree

0

0

0

0

0.0

(-)

Area

0

0

0

0

0.0

 

Other

 

*

*

*

*

 

Fluorescein

/

U

/

/

02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conjunctiva

Chemosis

0

0

0

0

0.0

(-)

 

Redness

0

0

0

0

0.0

(-)

 

Discharge

0

0

0

0

0.0

 

Iris

 

0

0

0

0

0.0

(-)

Corneaopacity

Degree

0

0

0

0

0.0

(-)

 

Area

0

0

0

0

0.0

 

Other

 

*

*

*

*

 

Fluorescein

 

/

U

/

/

03

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conjunctiva

Chemosis

1

1

0

0

0.3

(-)

 

Redness

1

1

0

0

0.3

(-)

 

Discharge

0

0

0

0

0.0

 

Iris

 

0

0

0

0

0.0

(-)

Corneaopacity

Degree

0

0

0

0

0.0

(-)

 

Area

0

0

0

0

0.0

 

Other

 

*

*

*

*

 

Fluorescein

 

/

U

/

/

 h = hours

(+) = Irritating according to E.E.C. criterias

(-) = not irritating according to E.E.C. criterias

* = None

U = Fluorescein used batch No. 4746

/ = Fluorescein not used

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
100 mg of pure 1-Phenyl-3-methyl-5-Pyrazolone was instilled in rabbits eyes.It did not lead to irritation or corrosion. The registered substance is classified as non-irritant according to CLP regulation.
Executive summary:

This study was performed to assess the Acute eye irritation/corrosion properties of the registered substance (1-Phenyl-3-methyl-5-pyrazolone). The study protocol is equivalent or similar to 405 OECD Guideline method (dated February, 24th 1987)

Material and Method

In this study, 3 New Zeland white rabbits were used. Acclimatation period was at least 5 days before instillation with registered substance. 100mg of pure registered substance was instilled into the conjunctival sac of the left eye of the animals after gently pulling the lower lid away from the eye ball. The upper and lower lids were held together for several seconds to avoid any loss of test substance, and the eyes were not rinsed after administration of the test substance. The untreated right eye served as control, and the ocular reactions at 1, 24, 48 and 72 hours after instillation were assessed.

Results

No ocular reactions were observed in all animals.

Conclusion

100 mg of pure 1-Phenyl-3-methyl-5-Pyrazolone instilled in rabbits eyes did not lead to ocular irritation or corrosion on all animals. The registered substance is classified as non-irritant according to CLP regulation.