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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentations

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.5
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: thioglycolic acid
Supplier: Merck, Darmstadt, Germany
Batch: 597
Purity: 99%

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
6
Details on study design:
not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: all
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal: all
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal: all
Time point:
24/48/72 h
Remarks on result:
other: not reported
Irritation parameter:
chemosis score
Basis:
animal: all
Time point:
24/48/72 h
Remarks on result:
other: not reported

Any other information on results incl. tables

Whitening of the conjunctiva due to corrosion and prevented scoring for  erythema, defaulting to a maximum score of 3 for erythema. The score  given for corneal opacity also reached the maximum of 4.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

The eye irritation potential of thioglycolic acid has been investigated in rabbits in a study compliant with the OECD guidelines# 405. 0.1 ml of neat thioglycolic acid was instilled into the eyes of 1 rabbit, followed by grading at various times between 4 hours and 72 or 96 hours. Whitening of the conjunctiva due to corrosion prevented scoring for erythema, defaulting to a maximum score of 3 for erythema. The score given for corneal opacity also reached the maximum of 4, there is no indications of the evaluation of the reversibility in the publication. Therefore, neat thioglycolic acid is considered as corrosive to the eyes.