Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TAME.
- Physical state: clear colorless liquid
- Analytical purity: 98.4 %
- Lot/batch No.: 25-30.11.89
- Storage condition of test material: room temperature, in darkness

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK
- Age at study initiation: not indicated
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: appr. 100-120 gram per animal/day
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / artificial illumination from 6 to 18 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the unexposed eye of each rabbit was the control
Amount / concentration applied:
100 µl TAME
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Eye irritation was recorded 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.
Number of animals or in vitro replicates:
3
Details on study design:
Three albino rabbits were administered 100 μl TAME to the conjunctival sac of one eye while the other remained as an untreated control. 24 hours after instillation, the test substance of the treated eye was rinsed with saline. Eye irritation was scored according to Draize and recorded 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: maximal score (2) at 24 and 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects were seen at all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects were seen at all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 24 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: maximal score (4) at 1 hour. The effects were observed in only one of the animals.
Irritant / corrosive response data:
The data do not imply classifying TAME as an eye irritating substance.
Other effects:
Discharge (grade 2-3) was observed after 1 hour in all three animals.

Applicant's summary and conclusion