2-chloro-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: OECD Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-chloro-N,N-dimethyl-3-oxobutyramide

EC Number:

227-372-9

EC Name:

2-chloro-N,N-dimethyl-3-oxobutyramide

Cas Number:

5810-11-7

Molecular formula:

C6H10ClNO2

IUPAC Name:

2-chloro-N,N-dimethyl-3-oxobutanamide

Details on test material:

Name: Dimetbyl- 2-ch1oroacetoacetamide
Batch No.: 502001
Physical state: clear yellowish liquid
Density: 1.20 g/m3
Storage: ambient, protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: rabbit
Strain: White New Zealands
Source: E.A. Prinzhorn, Altenbiicker Damm 38, D-27333 Altenbiicken
Animal identification: with individual ear tags; cage labelled with ear tag no., sex, date of study initiation, project no.
Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
lllumination: artificial Lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature:20 +/- 3 °C
Relative humidity: 30 -70 %
Measurement: twice daily

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

One animal was used. In the animal, 0.1 m1 of the test article was introduced into the
conjunctival sac of the left eye, the untreated right eye served as contro!.

Observation period (in vivo):

Ocular reactions were assessed 1, 24, 48 and 72 h after treatment and thereafter once daily up to day 21 post applicationem. On each occasion, ocular irritation was scored according to the scheme presented on the next two pages. Additional findings were recorded.

Number of animals or in vitro replicates:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean

Score:

3.67

Max. score:

4

Reversibility:

not fully reversible within: 19 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean

Score:

0

Max. score:

0

Remarks on result:

other: Not determinable due to cornea opacity

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: man

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 19 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 19 days

Irritant / corrosive response data:

At 1 h p.a., an observation of the cornea and iris was not possible due to the extreme swelling of the eye. Severe corneal opacity was observed up to day 21 p.a. Therefore an evaluation of the iris was not possible during the entire observation period. Extreme redness and extreme swelling of the conjunctivae as well as moderate to extreme secretion were seen at 1 h. p.a. and during the first days p.a. These findings were still apparent in decreased severity up to day 21 p.a. Additionally, bleeding presumably from the episcleral vesseis was observed from day 5 p.a. up to the end of the observation period on day 21 p.a.

Other effects:

No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is corrosive to eyes

Executive summary:

The potential toxicity of Dimetbyl-2-ch1oroacetoacetamide was assessed in a preliminary acute eye irritation/corrosion test using one albino rabbit according to OECD Guideline 405. In the animal, 0.1 ml of the test article was introduced into the conjunctival sac of one eye, the untreated eye served as control. Both eyes were examined at 1, 24, 48 and 72 h post applicationem and thereafter once daily up to day 21 post applicationem. In this animal, severe corneal opacity, extreme redness and extreme swelling of the conjunctivae were observed. Additionally, bleeding presumably from the episcleral vessels and extreme ocular secretion were seen. These findings were not reversible within 21 days p.a. No other toxic effects were