2'-methylacetoacetanilide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-05-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study documented and performed according to GLP standards and in compliance with Directive 84/449/EC, Part B, Method B5.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not applicable

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2'-methylacetoacetanilide

EC Number:

202-267-0

EC Name:

2'-methylacetoacetanilide

Cas Number:

93-68-5

Molecular formula:

C11H13NO2

IUPAC Name:

N-(2-methylphenyl)-3-oxobutanamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Sample designation: P0012
Physical state: white powder
Storage: ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White strain rabbits in the weight range 2.1 to 3.3 kg, prior to treatment on Day 1 and approximately 9 to 14 weeks of age were
obtained from Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire and A. Smith, Warlinghani, Surrey, England.
The rabbits selected for the study were all acclimated to the laboratory environment.
The rabbits were individually housed in metal cages with perforated floors in Building R 14 Rooms 1 and 4. They had free access to tap water and SDS Standard Rabbit Diet.
Aninial room temperature was maintained at approximately 19°C and relative humidity at 30—70%.
Air exchange was maintained at approximately 19 air changes per hour and lighting was controllecl to give 12 hours of artificial light (0700—1900
hours) in each 24 hour period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Approximately 89 mg of test item, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal.

Duration of treatment / exposure:

The eyelids were gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.

Observation period (in vivo):

Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation. Observation of the eyes was aided by the use of
a handheld torch.

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or
conjunctival inflammation.
Approximately 89 mg of P0012, the weight occupying a volume of 0.1 ml, 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. The contralateral eye remained untreated and served as a control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24 , 48, 72 hours and 7 day

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24 , 48, 72 hours and 7 day

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24 , 48, 72 hours and 7 days

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

The numerical scores awarded to the ocular reactions elicited by the test item are given under "any other information on results incl. tables".

Other effects:

No corneal damage or iridial inflammation was seen throughout the observation period.
Mild conjunctival inflammation was evident in all three animals. All reactions had resolved by the following day.

Any other information on results incl. tables

Animal No.	1	2	3
3 hours/days	1  24  48  72  7	1  24  48  72  7	1  24  48  72  7
Cornea
E = Degree	0	0	0
F = Area	0	0	0
(F x E) x 5	0	0	0
D = Iris	0	0	0
D x 5	0	0	0
Conjunctiva
A = Redness	1   0   0   0   0	1   0   0   0   0	1   0   0   0   0
B = Chemosis	0   0   0   0   0	1   0   0   0   0	1   0   0   0   0
C = Discharge
(A + B+ C) x 2	2   0   0   0   0	4   0   0   0   0	4   0   0   0   0
Total	2   0   0   0   0	4    0   0   0   0	4   0   0   0   0

Group mean score at 1h: 3 Group mean score at 72h: 0 Maximum mean score: 3

Group mean score at 24h: 0 Group mean score at 7d: 0

Group mean score at 48h: 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test item is not irritating to the eye according to the GHS Classification criteria.

Executive summary:

The experimental procedure complied with EEC Methods for determination of toxicity Directive 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B5 Acute toxicity (eye irritation).

Three New Zealand White strain albino rabbits were chosen as it has been shown to be a suitable model for eye irritation studies and is the animal recommended in the test protocol.

The test substance was administered as supplied by the Sponsor. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.

No corneal damage or iridial inflammation was seen throughout the observation period. Mild conjunctival inflammation was evident in all three animals. All reactions had resolved by the following day.

In conclusion, Acetoacet-o-toluidide is not irritating to the rabbit eye and therefore has not been classified according to GHS.