3-methyl-1-phenyl-5-pyrazolone

Eye irritation

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

Test material information

Constituent 1

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-2,4-dihydro-3H-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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Results 11

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

Results 12

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.