Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Mar. 15, 1988 to Apr. 22, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guideline, with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
EC Number:
403-920-4
EC Name:
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
Cas Number:
107551-67-7
Molecular formula:
C13H18O3
IUPAC Name:
3-(3-tert-butyl-4-hydroxyphenyl)propanoic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
- Age at study initiation: Approximately 12-14 weeks old.
- Weight at study initiation: 2710 to 2790 g.
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C.
- Humidity (%): 30-70%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (61 mg).
Duration of treatment / exposure:
Single exposure (1 second).
Observation period (in vivo):
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of TK 13010/ZP according to the OECD scoring system.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: OECD scoring system; EU classification.
TOOL USED TO ASSESS SCORE: A slit-lamp was used to facilitate the evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24-72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Iris reactions: Grade 1 reactions were observed at all time points (1-72 hour) in all animals.
Corneal reactions: Grade 1 reactions were observed at all time points (1-72 hour) in all animals.
Conjunctival redness: Grade 2 reactions were observed at all time points (1-72 hour) in all animals except a grade 3 reaction in one animal at 24 hours.
Conjunctival chemosis: Awaiting response. The observation period was extended to 10 days at which time no eye reactions were observed.
Refer to Table 1.
Other effects:
A moderate loss of weight was observed in one animal on day 3. Refer to Table 2.

Any other information on results incl. tables

Table 1 Individual eye scores

 

CORNEA

IRIS

CONJUNCTIVA

ce/te

ce/te

ce/te

ce/te

Animal No. 70/F

After 1 hr.

0/1

0/1

0/2

0/2

After 24 hrs.

0/1

0/1

0/2

0/2

After 48 hrs.

0/1

0/1

0/2

0/1

After 72 hrs.

0/1

0/1

0/2

0/1

mean (24-72

hrs. )

0/1

0/1

0/2

0/1.33

After 7 days

0/1

0/0

0/1

0/0

After 10 days

0/0

0/0

0/0

0/0

Animal No. 71/F

After 1 hr.

0/1

0/1

0/2

0/2

After 24 hrs.

0/1

0/1

0/2

0/3

After 48 hrs.

0/1

0/1

0/2

0/2

After 72 hrs.

0/1

0/1

0/2

0/2

mean (24-72

hrs. )

0/1

0/1

0/2

0/2.33

After 7 days

0/1

0/0

0/1

0/1

After 10 days

0/0

0/0

0/0

0/0

Animal No. 72/F

After 1 hr.

0/1

0/1

0/2

0/2

After 24 hrs.

0/1

0/1

0/3

0/2

After 48 hrs.

0/1

0/1

0/2

0/1

After 72 hrs.

0/1

0/1

0/2

0/1

mean (24-72

hrs. )

0/1

0/1

0/2.33

0/1.33

After 7 days

0/0

0/0

0/1

0/0

After 10 days

0/0

0/0

0/0

0/0

Ce = control eye; te = test eye

F = female M = male

Table 2 Body weights

animal no.

70 /F

71 /F

72 /F

at start

2710

2790

2770

after 3 days

2800

2810

2700

after 7 days

2810

2880

2860

after 10 days (end)

2830

3010

2940

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Under the experimental conditions the test item induced significant irritation of the cornea, iris and conjunctiva. According to the EC Directive No. 83/467/1983 the test substance must be classified as irritant to the albino rabbit eye (R36). The reactions were reversible until the reading of 10 days after instillation.