N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[(E)-2-[2-methoxy-5-(phenylcarbamoyl)phenyl]diazen-1-yl]naphthalene-2-carboxamide; N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[(E)-2-[2-methoxy-5-(phenylcarbamoyl)phenyl]diazen-1-yl]naphthalene-2-carboxamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 06 Jun 2011 to 16 JUN 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 405), in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

Reference substance 001

Cas Number:

99402-80-9

Test material form:

solid: nanoform, no surface treatment

Details on test material:

Name of test material (as cited in study report): Part of several studies carried out by Eurofins (see study record for report name); DCC Carmine 6BL;
Analytical purity: not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Robinson Services, Inc.
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually
- Diet: Harlan Teklad Global High Fiber Rabbit Diet 2031 ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL (0.03 g)

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

2 females, 1 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: in accordance with OECD TG 405.
Scores were read 1, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 24 h reading

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: reversibility not relevant since no effect

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effect

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not relevant since no effects

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effect

Irritant / corrosive response data:

Iris, and cornea scores were 0 for all three animals at all time points (1, 24, 48 and 72 h). Conjunctiva redness and chemosis scores were also 0 for all three animals at 24, 48 and 72 h reading. Only one female showed slight chemosis at the 1 h reading (score 1, animal 2) and two animals (one male and one female, animal 1 and 2, respectively) showed slight redness (score 1 and 2, respectively) at the 1 hour reading. Slight discharge (score 2, 2, 1 in animal #1, 2, 3, respectively) was observed in all animals at the 1 h reading. All effects were fully reversible withing 24 hours.

Other effects:

All animals appeared active and healthy during the study. There were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not irritating to the eyes under the test conditions of OECD 405.

Executive summary:

Test material was subject to a test of eye irritancy according to OECD guideline 405. 30 mg (0.1 mL) of substance were applied to one eye of three animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. There was no corneal opacity or iritis observed in any treated eye during the study. Within one hour after test substance instillation, all three treated eyes exhibited conjunctivitis. All animals were free of ocular irritation by 24 hours. No other effects could be observed in any animal. Therefore, it is concluded that the test item is not irritating to eyes.