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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
secondary source
Title:
Toxicology Update: Triethylene glycol.
Author:
Ballantyne, B., Snellings, W.M.
Year:
2007
Bibliographic source:
J. Appl. Toxicol. 27, 291 - 299

Materials and methods

Principles of method if other than guideline:
Six New Zealand White rabbits were dosed with 0.1 mL of test material. The dose was instilled into the lower conjunctival sac of one eye. The eyes were scored according to Draize.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Batch no.: TS-3200424
- Appearance: Colorless, transparent viscous liquid
- Purity: 99.82%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Male and female rabbits are dosed with 0.1 mL. The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored according to Draize for 1 h, 4 h, 24 h, 48 h, 72 h and 7 days after dosing. Fluorescin (1%) staining is used to determine corneal injury before dosing and readings after 1 day.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

No corneal injury in any of 6 eyes, iritis in 6, minor (transient) conjunctival irritation in 6 (with moderate to substantial discharge in 5) with 0.1 mL; all healed at 24 hours.

Summary of eye scores:

     Observation times  1 h  4 h  24 h  48 h  72 h  7 days
   Animal No.  1  2  3  4  5  6
 Cornea  Opacity  Range  All 0  All 0  All 0  All 0  All 0  All 0
     Mean  0.0  0.0  0.0  0.0  0.0  0.0
   Area  Range  All 0  All 0  All 0  All 0  All 0  All 0
     Mean  0.0  0.0  0.0  0.0  0.0  0.0
 Iris  Injury  Range  All 1  0 - 1  All 0  All 0  All 0  All 0
     Mean  1.0  0.2  0.0  0.0  0.0  0.0
 Conjunctivae  Redness  Range All 1  All 1  All 0  All 0  All 0  All 0
     Mean  1.0  1.0  0.0  0.0  0.0  0.0
   Chemosis  Range  0 - 1  All 1  All 0  All 0  All 0  All 0
     Mean  0.8  1.0  0.0  0.0  0.0  0.0
   Discharge  Range  1 - 3  All 1  All 0  All 0  All 0  All 0
     Mean  2.2  1.0  0.0  0.0  0.0  0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met