1-phenyl-3-pyrazolidone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data from peer review publication

Data source

Reference

Reference Type:

publication

Title:

INTERLABORATORY ASSESSMENT OF THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) ASSAY

Author:

P. GAUTHERON et.al

Year:

1994

Bibliographic source:

Toxic. in Vitro, 1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC (1984 and 1991) and French (1984 and 1991) directives with few modifications

Principles of method if other than guideline:

The experiments were carried out according to the EEC (1984 and 1991) and French (1984 and 1991) directives, with few modifications: ocular lesions (cornea, iris and conjunctiva) were scored

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-phenyl-3-pyrazolidone

EC Number:

202-155-1

EC Name:

1-phenyl-3-pyrazolidone

Cas Number:

92-43-3

Molecular formula:

C9H10N2O

IUPAC Name:

1-phenylpyrazolidin-3-one

Test material form:

solid

Details on test material:

Name of test material (as cited in study report): 1-Phenyl-3-pyrazolidone
Molecular formula: C9H10NO
Molecular weight :162.191 g/mol
Smiles notation : c1ccc(cc1)N2CCC(=O)N2
InChl : 1S/C9H10N2O/c12-9-6-7-11(10-9)8-4-2-1-3-5-8/h1-5H,6-7H2,(H,10,12)
Substance Type: Organic
Physical State: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

No data

Duration of treatment / exposure:

No data

Observation period (in vivo):

1 hr, then at 1, 2, 3, 4, 7 and 14 days.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
Washing (if done): Yes , for 3 rabbits
Time after start of exposure: No data

SCORING SYSTEM: Only ocular lesions (cornea, iris and conjunctiva) were scored (Draize et al., 1944) at 1 hr, then at 1, 2, 3, 4, 7 and 14 days. In the case of positive score, eyes were also examined at 21 days.
Raw data were also used to classify chemicals according to the rating system described by Kay and Calandra (1962), and the EC criteria.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Day 1 score

Basis:

mean

Time point:

other: 1 hr

Score:

7.7

Reversibility:

fully reversible within: 4 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: Maximal Average Score (MAS)

Basis:

mean

Time point:

other: 1 hr

Score:

8.7

Reversibility:

fully reversible within: 4 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Non irritant according to EEC(1984) directives and Mild irritant according to Kay and Calandra (1962)

Any other information on results incl. tables

CAS	In vivo Scores		Reversibility (DAYS)	Class
	MAS	DAY 1		K-C*	EEC^#
92 -43 -3	8.7	7.7	4	Mild	NI

 

MAS – Maximal Average Score

* Kay and Calandra (1962):

PN=practically non-irritant; Min=minimally irritant; Mod=moderately irritant, Sev = severely irritant; Extr = extremely irritant; Max = maximally irritant.

 

# EEC (1984) risk phrases for ocular irritancy;

NI = non-irritant; R36 = irritant; R41 = severely irritant.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The MAS score for the test chemical was calculated to be 8.7 and score measured at day 1 was found to be 7.7.
The test chemical was classified as Non irritant according to EEC(1984) directives and Mild irritant according toKay and Calandra (1962).

Executive summary:

The test chemical was evaluated for in vivo eye irritation in rabbits.The tests were performed according to EEC (1984 and 1991) and French (1984 and 1991) directives with few modifications: ocular lesions (cornea, iris and conjunctiva) were scored.

Three rabbits were used per test compound, and maximal average score (MAS) as well as score at day 1 were calculated. At the request of the participants, any mass of material present in the conjunctival sac was removed after the 1-hr observation. Also, a fluorescein solution was used for observation of corneal lesions. Only ocular lesions (cornea, iris and conjunctiva) were scored (Draize et al.,1944) at 1 hr, then at 1, 2, 3, 4, 7 and 14 days. In the case of positive score, eyes were also examined at 21 days. Raw data were also used to classify chemicals according to the rating system described by Kay and Calandra (1962), and the EC criteria (1984). The MAS score for the test chemical was calculated to be 8.7 and score measured at day 1 was found to be 7.7.

The test chemical was classified as Non irritant according to EEC(1984) directives and Mild irritant according toKay and Calandra (1962).