3-(3-tert-butyl-4-hydroxyphenyl)propionic acid

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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.