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Toxicological information

Eye irritation

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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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: 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

Resultsopen allclose all
Irritation parameter:
other: erythema and edema
Basis:
other: all animals tested-unwashed eyes
Time point:
other: 1 hour
Remarks on result:
other: severe response
Irritation parameter:
overall irritation score
Basis:
other: all animals tested - unwashed eyes
Time point:
other: 14 days
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 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)

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.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
The test material was a strong eye irritant. The effects were considered non-reversible.