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other: Comparable to guideline study, GLP-compliance, available as unpublished report, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ETHYL THIURAD
- Physical state: off-white powder
- Purity: 98.6%
- Lot/batch No.: 5394

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Isaac’s Farm, Litchfield, Illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.16-2.37 kilograms
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 32 ± 1 mg, determined to occupy a volume of 0.1 mL of test material
Duration of treatment / exposure:
single eye instillation
Observation period (in vivo):
24, 48, 72 hours and 7 day
Number of animals or in vitro replicates:
6 animals (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No washing

SCORING SYSTEM: The method of Draize (1944)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
4.2
Max. score:
110
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 tested animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Iris values according to current EU classification criteria
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Iris values according to current EU classification criteria
Irritation parameter:
iris score
Basis:
mean
Remarks:
of the remaining 4 tested animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
reading at
Time point:
other: 24 h
Score:
16
Max. score:
20
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean of readings at
Time point:
other: 48 and 72 h
Score:
2
Max. score:
20
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
2.66
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
4
Max. score:
20
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
3.33
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
2.66
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
2.66
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: max. score as a sum of redness, chemosis and discharge
Irritant / corrosive response data:
Only one out of 6 tested animals showed stronger irritation of conjunctivae.

Any other information on results incl. tables

Table 1: Ethyl Thiurad: Primary Eye Irritation to Rabbits - Individual Irritation Scores*

Animal #

Obs. Day

Cornea

Iris

Conjunctivae

Total

Average of 24, 48 and 72 h

1

1

0

5

16

21

8.33

2

0

0

2

2

3

0

0

2

2

7

0

0

0

0

2

1

0

0

8

8

2.66

2

0

0

0

0

3

0

0

0

0

3

1

0

5

8

13

5.66

2

0

0

2

2

3

0

0

2

2

7

0

0

0

0

4

1

0

0

8

8

3.33

2

0

0

2

2

3

0

0

0

0

5

1

0

0

6

6

2.66

2

0

0

2

2

3

0

0

0

0

6

1

0

0

6

6

2.66

2

0

0

2

2

3

0

0

0

0

* Scores according to Draize, J.H. et al., 1944, J. Pharmacol. Exp. Therap. 82: 377-390.

Iris Values were given as total scores x 5

Conjunctivae values were given as total results from (A+B+C) x 2 with a total maximum of 20 (A = Redness, B = Chemosis and C = Discharge)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU