3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted May 12, 1981)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

EC Number:

226-107-4

EC Name:

3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

Cas Number:

5280-80-8

Molecular formula:

C44H38Cl4N8O6

IUPAC Name:

3,3'-{(2,5-dimethyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis[4-chloro-N-(5-chloro-2-methylphenyl)benzamide]

Test material form:

solid: particulate/powder

Details on test material:

Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature

Specific details on test material used for the study:

commercial grade

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410 - 2660 g
- Housing: individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau / Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: 5 days (23 June, 1983 - 27 June, 1983)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

see observation period (no washing conducted)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not done

SCORING SYSTEM: according to OECD 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal 1 -3)

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 24 - 48 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 24 - 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 - 72 h

Other effects:

The body weight development was not affected by the application of the test article. No other reactions to treatment were recorded during the whole observation period.

Any other information on results incl. tables

Table 1: Evaluation of the eye reactions

Animal	Reading	Cornea Opacity	Iris	Conjunctiva
				Redness	Chemosis
1	1 h	0	0	0	0
2	1 h	1	0	1	0
3	1 h	1	0	2	1
1	24 hrs	0	0	0	1
2	24 hrs	0	0	0	0
3	24 hrs	1	0	1	1
1	48 hrs	0	0	0	0
2	48 hrs	0	0	0	0
3	48 hrs	0	0	0	1
1	72 hrs	0	0	0	0
2	72 hrs	0	0	0	0
3	72 hrs	0	0	0	0
1	7 days	0	0	0	0
2	7 days	0	0	0	0
3	7 days	0	0	0	0
1	24/48/72 hrs	0	0	0	0.3
2	24/48/72 hrs	0	0	0	0
3	24/48/72 hrs	0.3	0	0.3	0.7
mean animal 1-3	24/48/72 hrs	0.1	0.0	0.1	0.3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present experiment the test substance was found to be slightly irritant and not corrosive when applied to the rabbit eye mucosa.

Executive summary:

An eye irritation test was performed with three male New Zealand White rabbits acc. to OECD 405 (Ciba-Geigy Ltd., 1983). Eyes were left unwashed after application of 0.1 g of test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0.1, 0, 0.1, and 0, respectively. After 48 hours all reactions were reversed. Under the conditions of the present experiment the test substance was found to be slightly irritant and not corrosive when applied to the rabbit eye mucosa. There was a clear tendency of recovery towards the end of the observation period and no classification according to EU- or EU-GHS-requirements is necessary.