5'-chloro-2'-methoxyacetoacetanilide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-11-28 to 1989-12-01

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 and OECD Guideline 405.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

not applicable

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5'-chloro-2'-methoxyacetoacetanilide

EC Number:

258-189-2

EC Name:

5'-chloro-2'-methoxyacetoacetanilide

Cas Number:

52793-11-0

Molecular formula:

C11H12ClNO3

IUPAC Name:

N-[5-chloro-2-(methoxyacetyl)phenyl]acetamide

Constituent 2

Reference substance name:

Acetessig-4-chlor-o-anisidid TTR

IUPAC Name:

Acetessig-4-chlor-o-anisidid TTR

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Physical state: white powder
Storage: in the dark at 20°C under a hood
Purity: > 99%
Batch: T021

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Examination of the eyes was made after 1, 24, 48 and 72 hours after instillation. Observation of the eyes was aided by the use of
a handheld torch.

Number of animals or in vitro replicates:

3

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 hour

Score:

8

Max. score:

8

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

5

Max. score:

6

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Other effects:

No corneal damage or iridial inflammation was seen throughout the observation period.
Conjunctival inflammation was evident in all three animals after one hour till 48 hours.
Conjunctival reddening and a slight swelling was noticed. Clear colorless eye defluxion was observed.
All reactions had resolved 72 hours after instillation.

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	2   1   1   0	2   2   1   0	2   2   1   0
B = Chemosis	1   0   0   0	1   1   0   0	1   1   0   0
C = Discharge	1 0 0 0	1 0 0 0	1 0 0 0
(A + B+ C) x 2	8  2   2   0	8   6   2   0	8   6   2   0
Total	8  2  2   0	8   6   2   0	8   6   2   0

Group mean score at 1h: 8                     Maximum mean score: 8

Group mean score at 24h: 5

Group mean score at 48h: 2

Group mean score at 72h: 0

Group mean score at 7d:----

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritating to the rabbit eye.

Executive summary:

The experimental procedure complied with EEC Methods for determination of toxicity Directive 84/449/EEC, Method B5 and OECD Guideline for testing of chemicals, 405. The study was documented and performed according to GLP standards.

Three New Zealand White strain albino rabbits were chosen in this test.

The test substance was administered unchanged in the conjunctival sac of the left eye.

Examination of the eyes were made after 1, 24, 48 and 72 hours after instillation.

No corneal damage or iridial inflammation was seen throughout the observation period. Conjunctival inflammation was evident in all three animals after one hour till 48 hours. All reactions had resolved 72 hours after instillation.

In conclusion, the test item is not irritating to the rabbit eye and therefore has not been classified as irritating and does not require labelling according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).