N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well conducted study according to that prescribed by Consumer Product safety Commission of the USA in The Code of Federal regulations, Title 16, section 1500.41. The principle of the test method is similar to the principle of the OECD Guideline 404 and no deviations have been reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Consumer Product safety Commission of the USA in The Code of Federal regulations, Title 16, section 1500.41

Deviations:

no

Principles of method if other than guideline:

Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbits, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layer thick, 0.5 ml (in case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substances. Dissolve solids in an appropriate solvent and apply the solution as for liquids. the animals are immobilized with pathes secured in place by adhesive tape. After 24 h exposure, the patches are removed and the resulting reactions are evaluated on the basis of designed values.

Erythema and Eschar Formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema Formation Value:
No oedema: 0
Very slight oedema (barely perceptible):1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1mm): 3
Severe oedema (raised more than 1mm and extending beyond area of exposure): 4


Reading are again made at the end of a total of 72h (48h after the first reading). An equal number of exposures are made on areas of skin that have been prevoiusly abraded. the abrasion are minor incision through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.The values for oedema and eschar at 24 and 72h for intact skin are addedd to the values for abraded. The total of the eight values is divided by four to give the primary irritation score.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide

EC Number:

245-950-9

EC Name:

N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide

Cas Number:

23949-66-8

Molecular formula:

C18H20N2O3

IUPAC Name:

N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)ethanediamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

six albino rabbits are used in abraded and intact skin tests.

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of test item powder was mixed with 0.5 ml of distilled water before application to the skin

Duration of treatment / exposure:

72 h

Observation period:

72 h

Number of animals:

12 rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Classification system recommended by ETAD subcommitee for toxicology:

0.0 - 0.5 - non-irritant
0.6 - 3.0 - slightly irritant
3.1 - 5.0 - moderately irritant
5.1 - 8.0 - severely irritant

None of the animals showed any observable response to treatment throughout the 72 hours observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test item is considered to be "non-irritant" to rabbit skin according to the system of classification recommended by the ETAD subcommitee for toxicology.

Executive summary:

A study conducted according to Consumer Product Safety Commission of the USA in The Code of Federal regulations, Title 16, section 1500.41. Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbits, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layer thick, 0.5 ml (in case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substances. Dissolve solids in an appropriate solvent and apply the solution as for liquids. the animals are immobilized with pathes secured in place by adhesive tape. After 24 h exposure, the patches are removed and the resulting reactions are evaluated on the basis of designed values.

Reading are again made at the end of a total of 72h (48h after the first reading). An equal number of exposures are made on areas of skin that have been prevoiusly abraded. the abrasion are minor incision through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.The values for oedema and eschar at 24 and 72h for intact skin are addedd to the values for abraded. The total of the eight values is divided by four to give the primary irritation score.