Registration Dossier

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
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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).

Categories Display