N,N-dimethyl-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: GLP study conducted in accordance with international guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyl-3-oxobutyramide

EC Number:

218-059-8

EC Name:

N,N-dimethyl-3-oxobutyramide

Cas Number:

2044-64-6

Molecular formula:

C6H11NO2

IUPAC Name:

N,N-dimethyl-3-oxobutyramide

Test material form:

other: Colourless to yellow

Details on test material:

Name of test material (as cited in study report): LZ705

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species and strain: New Zealand white rabbit
Hygienic level during the study: good conventional
Justification of strain: The New Zealand white rabbit is one of the standard animals in acute eye irritation study.
Number of animal: 3 males
Age of animals: adult rabbits
Body weight range at the beginning of the study: 2960 - 3020 g
Body weight range at the end of the study: 3044 - 3109 g
Date of receipt: October 04, 2012
Acclimatisation time: 5 days
Housing: Animal was housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
The animals received Rabbit fattening mixed diet produced by YAQ-TÁP Kft., Nyíregyháza (Tokaji út 22), Hungary, ad libitum.
Animals received tap water from watering bottles ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml of the test item LZ705 was used for the study in pure state, in a single dose. The absorption of the test item was not determined.

Duration of treatment / exposure:

The eyes of the test animals were not washed out after the application of test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after the application.

Number of animals or in vitro replicates:

3

Details on study design:

Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition, any with ocular lesions were rejected.
In the first step an initial test was performed using one animal. The test item was poured into the conjunctival sac of the left eye. The eyelids were held closed gently for several seconds to prevent the loss of the test item. The contralateral eye served as control. Immediately after the administration of
the test item, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first animal, two additional animals were treated. Before the administration the treated
eyes of animals were not anaesthetised, because the score of initial pain reaction was 3 in the first animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

0.33

Max. score:

0.66

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72h

Score:

0.33

Max. score:

0.33

Reversibility:

fully reversible

Irritant / corrosive response data:

One hour and 24 hours after the treatment some hyperemic blood vessels (score 1) were occurred in all animals. The swelling was different from normal (score 1) in all animals. Discharge with moistening of the lids and hairs just adjacent to lids (score 2) was observed in animal No.: 1746 and the
amount of discharge was different from normal (score 1) in two animals (No.: 1750, 1745).
48 hours after the treatment some hyperemic blood vessels (score 1) were found in animal No.: 1745. Two animals (No.: 1750, 1746) became free of
symptoms.
72 hours after the treatment all animals were free of eye irritation symptoms.

Other effects:

General state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.

Any other information on results incl. tables

Mean values of eye irritation scores for EU classification (24, 48 and 72 hours reading)

Species: NZW Rabbit

Dose: 0.1 ml

Sex: Male

Start of Exposition: October 09, 2012

Test Item: LZ705

Animal Number	Sex	Cornea Opacity	Iris	Conjunctivae
				Redness	Chemosis	Discharge
1750	male	0.00	0.00	0.33	0.33	0.33
1746	Male	0.00	0.00	0.33	0.33	0.33
1745	Male	0.00	0.00	0.66	0.33	0.33

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, test item LZ705 applied to the rabbits' eye mucosa, caused slight to moderate conjunctival irritant effects, fully reversible within
72 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.

Executive summary:

The eye irritation study to the rabbit was performed in October 2012 according to OECD Guideline 405 and GLP. The test item LZ705 applied to the rabbits' eye mucosa, caused slight to moderate conjunctival irritant effects, fully reversible within 72 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.