Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman institute, Someren, The Netherlands
- Age at study initiation:
- Weight at study initiation: 7 months
- Housing: in Lurane cages
- Diet and water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 40-75
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL was applied in the conjunctival sac of the right eye, the other eye served as control.
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : no

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: fluorescein 2% , 24 hours after tratment. in one animal, this treatment was repeated on day 10.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0 - 0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3 - 1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0 - 0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours

Any other information on results incl. tables

  Observation time after exposure Corneal Opacity Iris lesion Conjunctival redness Conjunctival swelling (chemosis) Mean corneal opacity (24/48/72 hours) Mean iris lesion score (24/48/72 hours) Mean Conjunctival redness score (24/48/72 hours) Mean Conjunctival swelling (24/48/72 hours)
Rabbit 1 1 h 0 0 1 1 0,3 0 0,3 0
  24 h 1d 0 1 0
  48 h 0 0 0 0
  72 h 0 0 0 0
  10 days 0 0 0 0
Rabbit 2 1 h 0 0 1 2 0 0 1 0,3
  24 h 0 0 1 1
  48 h 0 0 1 0
  72 h 0 0 1 0
  10 days 0 0 0 0
Rabbit 3 1 h 0 0 1 1 0 0 0,6 0,3
  24 h 0 0 1 1
  48 h 0 0 1 0
  72 h 0 0 0 0
  10 days 0 0 0 0

d: Fluorescein treatment revealed damage of 1 % of the corneal surface which was totally reversible for 10 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
TBEC was very sligthly irritating when administered by ocular route to rabbits.
Executive summary:

The potential of TBEC to induce ocular irritation was evaluated in rabbits in a test similar to OECD 405 guideline.

TBEC was administered undiluted to 3 New Zealand White rabbits in the conjunctival sac of one eye. The other eye was not treated and served as control. The eyes were not rinsed after administration of the test item.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours and 10 days after the administration. The mean values of the scores for corneal opacity chemosis, redness of the conjunctiva, iris lesions were calculated for each animal.

Only minor signs of irritation were observed. For one animal, fluorescein treatment revealed damage of 1 % of the corneal surface which was totally reversible for 10 days.

Under these experimental conditions, TBEC was therefore very slightly irritating when administered by ocular route to rabbits.