Reaction products of 1-naphtylamino-5-sulfonic acid, 1,3-diaminobenzene and 4,4'-dinitrostilbene-2,2'-disulfonic acid, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

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: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 238

IUPAC Name:

Acid Brown 238

Test material form:

solid: particulate/powder

Details on test material:

The substance was suspended in tap water before the administration.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
Strain: Porton
Age at study initiation: 9-13 weeks
Weight at study initiation: 2.36 Kgs. (males) and 2.55 Kgs (female)
Housing: maintained under a semi-barrier system. Caged singly in an experimental room
Diet: bred on the premises and maintained under a semi-barrier system. Commercial irradiated diet (Styles-Oxoid) was fed ad lib
Water: ad libitum, Sterile filtered
Acclimation period: acclimatized in the test area for one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
Temperature: 20 °C +/- 1°C
Humidity: 50-70 %
Photoperiod (hrs dark / hrs light): from 08.00 - 18.00 hours artificial light

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.

Observation period (in vivo):

The eyes of the experimental animals were examined and found normal prior to the test.
14 days

Number of animals or in vitro replicates:

6 rabbits (3 male, 3 female)

Details on study design:

The test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. After 30 seconds the compound was, as far as possible, flushed out of the eyes- of three of the rabbits with warm water for 1 minute.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal:

Remarks:

all of six animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: all of the six animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: six animals/6

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: one animal/6

Time point:

48 h

Score:

0.17

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: all otf the six animals

Time point:

72 h

Score:

0

Results 6

Irritation parameter:

chemosis score

Basis:

animal: two anilmals/6

Time point:

24 h

Score:

0.83

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal: one animals/6

Time point:

48 h

Score:

0

Results 8

Irritation parameter:

chemosis score

Basis:

animal: six animals

Time point:

72 h

Score:

0

Irritant / corrosive response data:

A very slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. These reactions subsided slowly over the subsequent days until all had returned to normal by 48 hours (1/3 washed eyes), 6 days (2/3 washed eyes), 10 days (2/3 unwashed eyes) and 14 days (l/3 unwashed eyes). Staining of the conjunctivae by the compound was seen in all three unwashed eyes for up to 72 hours. Transient damage to the surface epithelium of the cornea was seen at one hour only in one rabbit (No.12).

Applicant's summary and conclusion

Interpretation of results:

other: minimal eye irritant

Remarks:

Criteria: Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

Conclusions:

minimal eye irritant in the albino rabbit

Executive summary:

The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous

Substances Labelling Act Sect. 191.11 (February 1965).

In to the left eye of six rabbits (3 male, 3 female) 100 g of the test compound was instilled into the conjunctival sac. The eyelids were then held closed for 1 second. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

Observation was done at 24 and 72 hours and 14 days.

A very slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. These reactions subsided slowly over the subsequent days until all had returned to normal by 48 hours (1/3 washed eyes), 6 days (2/3 washed eyes), 10 days (2/3 unwashed eyes) and 14 days (1/3 unwashed eyes). Staining of the conjunctivae by the compound was seen in all three unwashed eyes for up to 72 hours. Transient damage to the surface epithelium of the cornea was seen at one hour only in one rabbit (No.12).

The substance is considere minimal eye irritant in the albino rabbit.