Disodium 4,4'-dinitrostilbene-2,2'-disulphonate

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 1

Reference Type:

other: Authoritative data base

Title:

GCID 221778

Year:

2011

Bibliographic source:

ACToR (Aggregated Computational Toxicology Resource);Ciba-Geigy Limited (1986). Final Report FAT 90159/A. Acute eye irritation/corrosion study in the rabbit. Experimental Toxicology GU 2.1, Project No. 851037 (unpublished study)

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

ACTOR
Data is from U.S. Environmental Protection Agency Hazard Characterization Document

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-dinitrostilbene-2,2'-disulphonate

EC Number:

223-051-2

EC Name:

Disodium 4,4'-dinitrostilbene-2,2'-disulphonate

Cas Number:

3709-43-1

Molecular formula:

C14H10N2O10S2.2Na

IUPAC Name:

disodium 4,4'-dinitrostilbene-2,2'-disulphonate

Details on test material:

- Name of test material : disodium 4,4'-dinitrostilbene-2,2'-disulphonate
- Substance type: Organic
- Physical state: Solid
purity : (60% test substance; 35% water)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

water

Controls:

yes

Duration of treatment / exposure:

24 – 72 hour

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

conjustival redness score

Basis:

mean

Score:

1

Remarks on result:

other: Conjunctival redness scores of 1 (some blood vessels definitely hyperaemic) were observed up to 72 hours in one rabbit.

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Score:

1 - 2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Score:

1

Remarks on result:

other: Chemosis scores of 1 (any swelling above normal, including nictitating membrane) were observed at 1 and 24 hours in 2 animals and at 1 hour in the third animal.

Any other information on results incl. tables

Conjunctival redness scores of 1 (some blood vessels definitely hyperaemic) were observed up to 72 hours in one rabbit. In another rabbit, conjunctival scores of 2 (diffuse, crimson color, with individual vessels not easily discernable) were observed after 1 and 24 hours, and a score of 1 was observed at 48 hours. In the third rabbit, the conjunctival score at 1 hour was 2, followed by 1 at 24, 48 and 72 hours.

Chemosis scores of 1 (any swelling above normal, including nictitating membrane) were observed at 1 and 24 hours in 2 animals and at 1 hour in the third animal. All other scores were 0. The average scores for redness over the 24-72 period were 1 in all of the animals. The average scores for chemosis over the 24 - 72 period were 0.33, 0.33 and 0 in the three animals.

According to the EC classification, the results from 24 to 72 hours were classified as non-irritant (redness and chemosis scores >= 2.5 or 2, respectively were not obtained). The eye reactions were reversible until the end of the observation period on day 7. Slight weight loss was observed in two of the animals on day 3. Weights of all the animals on day 7 were greater than initial weights.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

disodium 4,4'-dinitrostilbene-2,2'-disulphonate was not irritating to rabbit eyes in this assay.

Executive summary:

New Zealand White rabbits (3 males) received an ocular administration of benzenesulfonic acid, 2,2’-(1,2-ethenediyl)bis[5-amino-, disodium salt] disodium 4,4’-dinitrostilbene-2,2’-disulphonate (60% test substance; 35% water) at 0.1 mL and observed for 7 days following treatment. The treated eye was not washed; the untreated eye served as control. The average scores for redness over the 24 – 72 hour period were one in all of the animals. The average scores for chemosis over the 24 – 72 hour period were 0.33, 0.33 and 0 in the three animals. Benzenesulfonic acid, 2,2’-(1,2-ethenediyl)bis[5-amino-, disodium salt] disodium 4,4’-dinitrostilbene-2,2’-disulphonate was not irritating to rabbit eyes in this assay.