2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

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: The test was performed in accordance with OECD and GLP guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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:

2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

EC Number:

228-768-4

EC Name:

2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

Cas Number:

6358-31-2

Molecular formula:

C18H18N4O6

IUPAC Name:

2-[(2-methoxy-4-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide

Test material form:

solid: nanoform, no surface treatment

Details on test material:

- Name of test material (as cited in study report): Hansa Brilliant Yellow 5GX IN
- Common name: C.I. Pigment Yellow 74

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Toxicology Department Rallis Research Centre, Bangalore, India
- Age at study initiation: 4 months
- Weight at study initiation: 2.43-2.66 kg
- Housing: individually in fibreboard cages
- Diet (e.g. ad libitum): Amrut rabbit feed, Nav Maharashta Chakan Oil Mills Ltd, Pune, India, ad libitum
- Water (e.g. ad libitum): purified deep bore well water, ad libitum
- Acclimation period: 7-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 30-70 % relative humidity
- Air changes (per hr): adequate fresh air supply
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 14 mg, equivalent to 0.1 ml

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after treatment end

Number of animals or in vitro replicates:

3

Details on study design:

SELECTION OF ANIMALS: The eyes of the rabbits were observed one day prior to the test item instillation for signs of eye irritation, ocular defects or pre-existing corneal injury and as the rabbits were free of all these signs, they were selected for the study.

REMOVAL OF TEST SUBSTANCE
- Washing: after 24 hours, the treated eye was irrigated with deionised water to remove residual test item; the control eye was washed similarly.
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draiz scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: after 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable since no effect

Remarks on result:

other: including opacity and area

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

other: after 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable since no effect

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of three animals

Time point:

other: after 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable since no effect

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

of three animals

Time point:

other: after 24, 48 and 72 hours

Score:

0.11

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

One animal showed a grade 1 conjunctival redness at the 24 hour reading. All other readings of conjunctival redness, chemosis, discharge, iris or cornea effects in all three animals at all reading times (1 hour, 24, 48 and 72 hours) were grade 0.

Other effects:

No pre-terminal deaths were observed. Body weights of all the rabbits increased during the observation period. No abnormal necropsy findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

67/548/EEC: Eye irritation: no classification warranted
1272/2008/EC: Eye irritation: no classification warranted

In an OECD guidline and GLP compliant eye irritation test in rabbits, a Hansa Brilliant Yellow 5GX IN (Pigment Yellow 74) did only cause very mild, transient signs of eye irritation, but has not to be classified as eye irritant.