Sodium hydrogen-5-sulphoisophthalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Although conducted prior to current protocol or GLP requirements, the study conformed to recognized protocols current at the time.

Justification for type of information:

The study was performed before non-animal test methods were available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

Conducted prior to current protocol and GLP requirements but by a method acceptable at the time. Based on the standard Draize test in common use.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydrogen-5-sulphoisophthalate

EC Number:

228-845-2

EC Name:

Sodium hydrogen-5-sulphoisophthalate

Cas Number:

6362-79-4

Molecular formula:

C8H6O7S.Na

IUPAC Name:

Sodium 3,5-dicarboxybenzenesulfonate

Constituent 2

Reference substance name:

288-845-2

IUPAC Name:

288-845-2

Constituent 3

Reference substance name:

Sodium hydrogen-5-sulphoisophalate

IUPAC Name:

Sodium hydrogen-5-sulphoisophalate

Constituent 4

Reference substance name:

5-(Sodiosulfo)isophthalic acid

IUPAC Name:

5-(Sodiosulfo)isophthalic acid

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: 5-(Sodiosulfo)isophthalic Acid
- Appearance/Physical form: powder
- Formula Weight: 268 g/mol
- Molecular Formula: C8H6O7S-1Na
- Purity: >92% (assay)
- Impurities: sodium sulfate,- Lot/batch No.: ARK BA103-81; X-17007-226

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

A few dry crystals

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

6

Details on study design:

A few dry crystals were placed into one eye from each of six rabbits. The eyes of three rabbits were immediately washed with distilled water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other:

Time point:

other: 1 hour

Remarks on result:

probability of severe irritation

Remarks:

The experiment was terminated based on severe effects

Results 2

Irritation parameter:

conjunctivae score

Basis:

other: All three animals with unwashed eyes

Time point:

other: 1 hour

Remarks on result:

probability of severe irritation

Remarks:

The experiment was terminated based on severe effects

Irritant / corrosive response data:

The experiment in rabbits with unwashed eyes was terminated based on severe effects observed after one hour.

Any other information on results incl. tables

The washed eyes exhibited slight to moderate erythema and edema after 1 hour; all three eyes appeared normal by 48 hours. In 2/3 washed eyes, fluorescein staining of the adnexa was observed.

Overall irritation score after 14 days (animals with unwashed eyes):

fluorescein staining of cornea/adnexa - 3/3 animals; scar tissue on eyelids (2/3); purulent discharge (1/3); bloody discharge (1/3); and moderate to severe corneal opacity (2/3). These observations indicate that the effect of the test item was non-reversible.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The test material was a strong eye irritant. The effects were considered non-reversible.