N-ethyl-N-(3-methylphenyl)propionamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 June to 10 July 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-ethyl-N-(3-methylphenyl)propionamide

EC Number:

423-640-6

EC Name:

N-ethyl-N-(3-methylphenyl)propionamide

Cas Number:

179911-08-1

Molecular formula:

C12H17NO

IUPAC Name:

N-ethyl-N-(3-methylphenyl)propanamide

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, England.
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.9 to 3.2 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: acclimatised to the experimental environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (07:00 - 19:00 hours) in each 24 hours period

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Amount: 0.1 ml

Duration of treatment / exposure:

A 0.1 ml amount of the test substance was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.

Duration of post- treatment incubation (in vitro):

Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, 7 and 14 days after instillation. Observation of the eyes was aided by the use of a handheld light.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
Cornea
Opacity: degree of density (area most dense taken for reading)

No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4


Area of cornea involved

One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneru hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or rul of these) 2


Conjunctivae
Redness (refers to the most severe reading of prupebrru and bulbar conjunctivae, as compared to the control eye)

Blood vessels normru 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individuru vessels not easily discernible 2
Diffuse beefy red 3


Chemosis (lids and/or nictating membranes)

No swelling 0
Any swelling above normru (includes nictating membranes) 1
Obvious swelling with partiru eversion of lids 2
Swelling with lids about hruf-closed 3
Swelling with lids more than hruf-closed 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 2971

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: 2971

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 2971

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: Day 7

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 2971

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: Day 7

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal: 2972

Time point:

24/48/72 h

Score:

2.66

Max. score:

4

Reversibility:

fully reversible within: Day 7

Results 6

Irritation parameter:

iris score

Basis:

animal: 2972

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: 2972

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: Day 14

Results 8

Irritation parameter:

chemosis score

Basis:

animal: 2972

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: Day 14

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal: 2973

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal: 2973

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal: 2973

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: Day 7

Results 12

Irritation parameter:

chemosis score

Basis:

animal: 2973

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: Day 7

Irritant / corrosive response data:

Corneal opacification (Grade 4) developed in one animal within 48 hours of treatment. No iridial inflammation was observed.

A diffuse crimson colouration of the conjunctivae was seen in all three animals accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed. The eyes were normal seven days after instillation in two animals and by 14 days after treatment in the remaining animal.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Instillation of the test item into the rabbit eye elicited transient corneal opacification and well-defined conjunctival irritation.

Executive summary:

A study was performed to assess the eye irritation potential of Agarbois using the rabbit. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.5. Acute toxicity (eye irritation).

Three rabbits were each administrated a single ocular dose of 0.1 ml of the test substance and observed for up to 14 days after treatment.

 

A single instillation of the test item into the eye of the rabbit elicited corneal opacitication and well­ defined conjunctival irritation. All reactions had resolved by 14 days after instillation.

Under the test conditions, the test item is classified as irritating to eyes category 2 according to the Regulation (EC) No. 1272/2008 (CLP).