N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-2-amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5.11.2012 - 12.11.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

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:

N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-1-amine

EC Number:

260-124-8

EC Name:

N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-1-amine

Cas Number:

56358-09-9

Molecular formula:

C32H37N5

IUPAC Name:

N-(2-ethylhexyl)-1-({2-methyl-4-[(2-methylphenyl)diazenyl]phenyl}diazenyl)-1,2-dihydronaphthalen-2-amine

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Solvent Red 19E
- Physical state: dark viscous liquid/borderline waxy solid
- Analytical purity: 90% (w/w)
- Impurities (identity and concentrations): Solvent Red24 (CAS 85-83-6) 2% (w/w)
- Lot/batch No.: S2409
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: in tightly closed containers in dark and well ventilated place at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.4 - 4 kg
- Housing: Individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet for rabbits and guinea pigs ad libitum
- Water (e.g. ad libitum): Drinking tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Relative humidity (%): 30-70 %
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark

STUDY TIME SCHEDULE
Animal supply: 17.10. 2012
Experimental part of study: 5.11.2012 – 12. 11. 2012

Test system

Vehicle:

other: olive oil

Remarks:

10 % w/v solution

Controls:

other: The second eye was treated with olive oil and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 10 % (w/v) solution in olive oil. This was the maximum technically practicable.
- The dose of 0.1 mL of test substance solution was applied to the eye of the animal by syringe.

VEHICLE
- Lot/batch no. (if required): 5211201

Duration of treatment / exposure:

72 h

Observation period (in vivo):

1, 24, 48 and 72 hrs

Number of animals or in vitro replicates:

Initial test: 1 female
Confirmatory test: 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to the grading system given in Method B.5 Acute Toxicity: Eye Irritation/Corrosion

TOOL USED TO ASSESS SCORE: After recording the observations at 72 hours, the eyes of rabbit were examined with the aid of fluorescein and the ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The control eyes in all rabbits were without ocular lesions during the whole study.

Other effects:

No symptoms of systemic toxicity were observed in the animals during clinical observations in the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The test material is not irritating to the eyes.

Executive summary:

The test material was assessed for eye irritation/corrosion according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, and OECD Test guideline 405.

The test was performed initially using one animal. Because no corrosive or severe irritating effects were observed in initial test, the response was confirmed using two additional animals.

No pathological changes of eyes of all rabbits were observed during whole study. During the observation period (at 1, 24, 48 and 72 hours after application) no irritating effects of eye was observed in all animals.

No clinical signs of systemic intoxication were detected.

Evaluation of results after single application demonstrated that the test substance is not irritating for eye of rabbit.