2,2`-[6-(phenylamino)-heteromonocycle-2,4-diyl]diphenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted April 24, 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Directive 2004/73/EC, B.5 "Acute Toxicity: Eye Irritation/Corrosion"

Version / remarks:

April 29, 2004

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol

Cas Number:

1248-66-4

Molecular formula:

C21H16N4O2

IUPAC Name:

2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 15 weeks (male), 13, 15 weeks (females)
- Housing: Individually in stainless steel cages.
- Diet: ad libitum. Pelleted standard Provimi Kliba 3418 rabbit maintenance diet.
- Water: ad libitum. Community tap water from Fullinsdorf.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- 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 per animal

Duration of treatment / exposure:

The treated eyes were not rinsed after instillation

Observation period (in vivo):

1, 24, 48, 72 h, as well as 7 and 10 days after administration

Number of animals or in vitro replicates:

3 (males and females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 10 d

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:

other: Not eye irritant according to the CLP Regulation (EC) No. 1272/2008

Conclusions:

Under the conditions of the test, test item resulted to be not eye irritant.

Executive summary:

The eye irritation potential of the test item was investigated according to OECD Guideline No. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 and 10 days after test item instillation. 
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjuctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjuctivae were 0.33, 1.33 and 1.00 for reddening and 0.00, 0.33 and 0.33 for chemosis, respectively. 

The instillation of test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjuctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 10 days after treatment, the end of observation period for all animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed, although test item remnants were visible in the conjuctival sac 1 hour (all animals) and 24 hours (one animal) post treatment. No clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.