3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Eye irritation

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: Guideline study (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)

Version / remarks:

February 24, 1987

Deviations:

no

Remarks:

because the observed eye reactions were reversible within 48 hours and no further irritation reactions observed thereafter, the test was ended after the 72-hours evaluation.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

EC Number:

407-920-5

EC Name:

3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol

Cas Number:

6390-69-8

Molecular formula:

C28 H42 O2

IUPAC Name:

3,3',5,5'-tetra-tert-butyl-[1,1'-biphenyl]-2,2'-diol

Details on test material:

- Name of test material (as cited in study report): generic name CA 16-178
- Physical state: solid, powder
- Analytical purity: 97.7% (not specified in the study [Lab. sample], transfered from 28d study [BASF SE [Ciba-Geigy Ltd/884619]], with same Lot/batch)
- Lot/batch No.: A 88103 / Z 1572R
- Storage condition of test material: room temperature
- Other: gloves and face masks as safety precautions

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: approx. 12-14 weeks old
- Weight at study initiation: 2160 - 2400 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; ad libitum
- Water (e.g. ad libitum): fresh water; ad libitum
- Acclimation period: at least 5 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye remained untreated and served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (37 mg)

Duration of treatment / exposure:

test substance was not washed out

Observation period (in vivo):

Because the observed eye reactions were reversible within 48 hours and no further irritation reactions observed thereafter, the test was ended after the 72-hours evaluation.

Number of animals or in vitro replicates:

3 (all males)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none performed

SCORING SYSTEM: the ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test substance according to the OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72-hour

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: cornea reaction (score 1) was observed only in one animal after 1 through 24 hours, but was reversible within 48 hours)

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: iris reaction (score 1) was observed in all animals after 1 hour, but was reversible within 24 hours

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24-48-72-hour

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: conjunctiva redness (score 1) was observed in all animals after 1 through 24 hours, but was completely reversible within 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-72-hours

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: chemosis was (score 1) oberved in 3 animals after 1 hour and persisted in one animal after 24 hours, but was completely reversible within 24/48 hours

Irritant / corrosive response data:

Slight eye irritation was observed in all treated animals (score 1), but was generally present after 1 through 24 hours and completely reversible within 48 hours.

Other effects:

A moderate loss of weight was observed in one animal on day 3 (considered not to be treatment related; Table 1).

Any other information on results incl. tables

Table 1: Body weight (g)

Animal	First animals	Second animal	Third animal
Body weight at start of the test	2400	2340	2160
Body weight after 3 days (end)	2480	2430	2080

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information