Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to the Draize-test (1959). In contrast to OECD guideline 405, 6 animals instead of 3 were used. For 3 animals substance was washed out after 30 seconds, whereas for the remaining animals eyes were not washed. Observation period was stopped after 72 hrs since no effects were seen.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize-Test

Principles of method if other than guideline:

The test was conducted with slight modification according to the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)

GLP compliance:

no

Remarks:

(GLP was not mandatory when the study was done)

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

EC Number:

223-460-6

EC Name:

N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

Cas Number:

3905-19-9

Molecular formula:

C40H24Cl4N6O4

IUPAC Name:

N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]

Details on test material:

- Physical state: powder, red
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.6 kg (male, average), 2.0 kg (female, average)
- Diet (e.g. ad libitum): commercial irradiated (Styles-Oxoid), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 40 mg

Duration of treatment / exposure:

for 3 animals test substance was washed out after 30 s
for 3 animals no washing out was performed

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6 (4 males, 2 females)

Details on study design:

SCORING SYSTEM:
Scoring according to the Draize system ( "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

for each animal

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: no corneal opacity detected after 24, 48, 72 hrs

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

for each animal

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: no iritis detected after 24, 48, 72 hrs

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

for each animal

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: no conjunctival redness detected after 24, 48, 72 hrs

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

for each animal

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: no chemosis detected after 24, 48, and 72 hrs

Irritant / corrosive response data:

A transient conjunctival reaction was seen in 2/3 unwashed and 1/3 washed eyes one hour after application. In one case the effect persisted for 6 hrs.
All eyes were normal at 24 hours. For regulatory purposes only time points of 24, 48, 72 hrs are considered, therefore test substance is defined as non-irritating.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information