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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 50 µl of the test substance was applied to the conjunctival sac of one eye in 2 animals. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrahydrolinalool (THL); Substance-ID: XXVI 402
- Physical state: fluid
- Analytical purity: > 98%
- Molecular weight (if other than submission substance): 158 g/mol
- Other: pH 7
- Solubility: water: no; alcohol: yes

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.74 kg; female: 2.16 kg
- Diet: Ssniff ad libitum
- water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the respective animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied 0.05 ml
- Concentration: 100%
Duration of treatment / exposure:
not specified (single application, substance was not washed out)
Observation period (in vivo):
8 days; observations at 10 min, 1 h, 3 h, 24 h, 48 h, 5 d, 7 d, 8 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-2
Time point:
other: 24, 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-2
Time point:
other: 24, 48 hours
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-2
Time point:
other: 24, 48 hours
Score:
0.75
Max. score:
4
Reversibility:
not fully reversible within: 5 days
Other effects:
Residual test substance or smeary layer on the eye.
In 1 animal small retraction of the eye lid (irregular margin) was observed at the end of the observation period, which was described as Na (= Narbe/Scar) in the original German report.
This finding is not the sequel of irreversible tissue destruction as suggested by the misleading historical wording and does not impair the ocular function.
Thus, it is not relevant for evaluation.

Any other information on results incl. tables

Scores for iris, cornea and conjunctiva:

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1h

1

-

-

1

0

smeary charge

2

-

-

1

1

smeary charge

24 h

1

1

-

1

1

smeary charge

2

1

-

2

1

smeary charge

48 h

1

1

-

1

-

2

1

-

2

1

d 5

1

1

-

1

-

2

1

-

1

-

d 7

1

-

-

1

-

2

-

-

1

-

d 8

1

-

-

1

-

2

-

-

1

-

scars

Mean

24, 48 h

1

1

-

1

0.5

2

1

-

2

1

Mean 24, 48 h

animals

1 -2

1

-

1.5

0.75

Observations after 8 days with fluorescein: no findings

- = not observed

Applicant's summary and conclusion