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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: Comparable to Guideline study with acceptable restrictions (no GLP study, only 50 µl applied, partly limited documentation, e.g. no details about the test substance [TS] or scoring 1 h after instillation)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye treated with physiological saline
Amount / concentration applied:
undiluted
Amount applied: 0.05 ml into the conjunctival sac
Duration of treatment / exposure:
Eyes were not rinsed.
Observation period (in vivo):
Scoring:
Several times on application day and 24 hrs, 48 hrs, 72 hrs as well as 6 and 8 days after application .
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
1
Reversibility:
fully reversible within: 6 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 6 d
Irritation parameter:
iris score
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 8 d
Irritant / corrosive response data:
As documented in the table below slight corneal opacity, conjunctival redness and slight or moderate conjunctival edema was found. Findings were reversible within the 3 or 8-day observation period. The control eyes which were treated with sodium chloride did not show any reactions.
Other effects:
no

Any other information on results incl. tables

Irritation Scores 

Effect redness chemosis corneal opacity iritis
rabbit No. 1 2 1 2 1 2 1 2

time after
treatment
24 h 1 1 2 0 1 0 0 0
48 h 1 1 1 0 1 0 0 0
72 h 1 0 0 0 1 0 0 0
6 days 0 nd 0 nd 1 nd 0 nd
8 days 0 nd 0 nd 0 nd 0 nd

nd: not determined

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The substance caused only slight irritation to the rabbit eye after instillation of 0.05 ml thiodiglycol.
Executive summary:

Comparable to Guideline study with acceptable restrictions (no GLP study, only 50 µl applied, partly limited documentation, e.g. no details about the test substance or scoring 1 h after instillation)

Thiodiglycol (0.05 ml) was instilled into the conjunctival sac of one eye of each of 2 White Vienna rabbits (not rinsed). Effects were scored 24, 48, and 72 hours as well as 6 and 8 days after treatment. The 1st rabbit showed slight conjunctival redness (Draize score 1 at 24 - 72 hours) and moderate (Draize score 2 at 24 hours) to slight (Draize score 1 at 48 hours) conjunctival chemosis, slight corneal opacity (Draize score 1 at 24 hours up to day 6) but no iritis. All effects were reversible at day 8 (study end). In the 2nd rabbit no effects were detected except a slight redness (Draize score 1) 24 and 48 hours after instillation.

Conclusion: The substance caused only slight irritation to the rabbit eye after instillation of 0.05 ml thiodiglycol.