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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0,5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 Hours

Number of animals:

3

Details on study design:

24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was examined for abrasions and only animals with healthy, intact skin were used in the test. In each animal, 0.5 ml of the test article were applied to the test site (ca. 6 cm2 in size), an adjacent area of untreated skin served as control. Each skin area was covered with a semi-occlusive dressing, which enveloped the whole of the animal's trunk. The duration of exposure was 4 h.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 15 days

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 11 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean

Score:

1.33

Max. score:

2

Reversibility:

not fully reversible within: 15 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 11 days

Irritant / corrosive response data:

Slight to moderate redness and moderate to severe swelling were observed 1 h after patch removal in all animals. These findings were still apparent up to day 7 p.a. in animal no. 3, up to day 9 (redness) or 12 (swelling) in animal no. 2 and up to the end of the observation period at day 15 after patch removal in animal no. 1. Additionally,
dark discoloration and induration of the treated skin areas as well as scale formation were seen.
The observed findings were not fully reversible within 15 days after patch removal.

Other effects:

No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is irritating to the skin under the conditions used.

Executive summary:

The potential toxicity of Dimethy1- 2-chIoroacetoacetamide (97.4% purity) was assessed according to OECD Guideline 404 in an acute dermal irritation/corrosion test on 3 albino rabbits. The skin was exposed to the test article for 4 h. Animals were examined for signs of erythema and oedema at 60 min, 24, 48 and 72 h and thereafter once daily up to day 15 after patch removal. Slight to moderate redness and moderate to severe swelling were observed. Additionally, dark discoloration and induration of the treated skin areas as well as scale formation were seen. In one animal the observed findings were not fully reversible within 15 days p.a.