Thiodiglycol

Eye irritation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Thiodiglycol

EC Number:

203-874-3

EC Name:

Thiodiglycol

Cas Number:

111-48-8

Molecular formula:

C4H10O2S

IUPAC Name:

2-[(2-hydroxyethyl)sulfanyl]ethan-1-ol

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

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.83

Max. score:

1

Reversibility:

fully reversible within: 6 d

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

2

Reversibility:

fully reversible within: 6 d

Results 3

Irritation parameter:

iris score

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

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.