N,N-Diethylacrylamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1993-05-24 to 1993-06-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1984

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-diethylprop-2-enamide

EC Number:

679-769-5

Cas Number:

2675-94-7

Molecular formula:

C7-H13-N-O

IUPAC Name:

N,N-diethylprop-2-enamide

Specific details on test material used for the study:

Batch No.: not specified
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: England
- Age at study initiation: approximately 14 weeks age
- Weight at study initiation: 3334g
- Housing: be housed individually in a plastic cage with a perforated floor
- Diet: ad libitum
- Water: ad libitum

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

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

1

Details on study design:

The eye were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.

One animal was treated in advance of the others, to ensure that if severe response was produced. No further animals would be exposed.

A 0.1 mL amount of the test substance was placed into the everted lid of one eye.

The eyelids were then gently held together for one second before releasing. The contralateral eye reminded untreated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

A corneal opacity developed one day after instillation. (Dulling and stripping of the epithelial cells were seen one hour after installation).

Iridial inflammation was observed one hour after instillation and 24 hours after installation has developed to Grade 2.

A beefy red colouration of the conjunctive accompanied by considerable swelling with partial eversion of the eyelids was observed. Blanching was observed in the nictating membrane.

Due to the severity of the reaction no further animals were exposure to the test item.

Any other information on results incl. tables

Ocular reations observed after instillation of the test item

rabbit number and sex	region of eye		1 hour	day after installation
				1	2	3	4	7	14	21
1849 male*	cornea		DA	1	1	1	1	1	1	0
	iris		1	2	1	1	1	0	0	0
	conjunctiva	redness	B2	B2	B2	B3	B3	B2	B2	0
		chemosis	2	2	2	2	2	1	1	0

* pilot animal

A stripping of the nictating

B blanching on the nictating membrane

D dulling of the normal lustre of the cornea

Applicant's summary and conclusion

Conclusions:

Instillation of test item into rabbit eye elicited severe ocular lesions.
Due to the severity of the reaction no further animals were exposure to the test item.

Executive summary:

The study was performed to assess the eye irritation potential of the rabbit. The method followed was in EEC methods for the determination of toxicity, Directive 84/449/EEC, part B, Method B.5. Acute toxicity (eye irritation).

 

One rabbit was administered a single ocular dose of 0.1 mL of the test item and observed for 21 days after instillation.

 

A single instillation of the test item into eye of the rabbit elicited severe ocular lesions.

 

In view of the severity of the ocular reactions seen no further testing was performed.