Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

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:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

0ECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Imitation/Corrosion" referenced as Method B5 in Comrnission Directive 84/449/EEC (which constitutes Annex V of Council Di recti ve 67 /548/EEC.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

EC Number:

274-366-7

EC Name:

Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

Cas Number:

70179-77-0

Molecular formula:

C28H30N2O8S.Na

IUPAC Name:

sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

Test material form:

solid: particulate/powder

Details on test material:

Sponsor's identification NYVIT
Batch number Op 1S 1005
Date received 21 May 1991
Description dark maroon powder
Container opaque plastic bottle
Storage conditions room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg/animal; undiluted

Duration of treatment / exposure:

no washing

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

one rabbit was initially treated. The test material (100 mg) was placed into the coniunctival sac of the right eye, formed by gently pulling the lower Iid away from the eyeball. The upper and lower eyelids were held together for about one second irunediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Irmediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/iwitation was made approximately I hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").
Any other adverse ocular effects were also noted. Examination of the eye was faciIitated by use of the Iight source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

ca. 0.75

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of weak irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, produced a maximum group mean score of 0.75 and was a weak irritant to the rabbit conjunctivae.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand Wlhite rabbit. The method used

followed that described in the 0ECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Imitation/Corrosion" referenced as Method B5

in Conrnission Directive 84/449/EEC (which constitutes Annex V of Council Directi ve 67 /548/EEC)

A single application of the test material to the non-irrigated eye of three rabbits produced moderate coniunctival irritation. Neither corneal nor iridal effects were seen. All treated eyes appeared normal 72 hours after treatment

The test material produced a maximum group mean score of 0.75 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material was also classified as non-irritant according to EEC labelling regulations.