1,3-Benzenediol, 4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, OECD guideline conform, well documented, read across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

440-520-9

EC Name:

-

IUPAC Name:

440-520-9

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne / France
- Age at study initiation: 14 weeks (male), 12-13 weeks (females)
- Weight at study initiation: 2398g (male), 2742 g (female), 2681 g (female)
- Housing: Individually
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 93/01) provided by Provimi Kliba AG, Kaiseraugst.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects observed.

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

2

Reversibility:

other: No effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Redness was observed after one hour.

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: one hour

Remarks on result:

other: Slight redness was observed after one hour.

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24 - 48- 72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Redness was observed after one hour.

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects observed.

Remarks on result:

other: Slight redness was observed after one hour in 2 animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU