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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study pre-dating OECD protocolls and GLP requirements. However, slight shortcomings regards documentation (e.g.number of animals, number of animals per dose ) justify a Klimisch 2 rating (reliable with restrictions).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

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

Details on test material:

It is reported the trade name of the test item.

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male

Details on test animals or test system and environmental conditions:

The male rats weighted from 236 to 242 grams.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: the test item pulver was prepared as a 40% suspension in aqueous gum tragacanth (0.5%)

Details on dermal exposure:

One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers exposing an area equivalent to 10% of the total body surface. No shaving or chemical depilation was used.

Duration of exposure:

The exposure period was of 24 hours. The skin of the animals was then decontaminated by washing with warm (40-50°C) dilute soap solution, rinsing in clean warm water and finally blotting dry with absorbent paper. The decontamonated animals were returned to their cages for a subsequent observation period of 14 days, during which a record was kept of all signs of toxicity.

Doses:

The test item was prepared as a 40% suspension in aqueous gum tragacanth (0.5%) and administrated at a dosage volume of 12.5 ml/Kg bodyweight by spreading evenly over the prepared skin.

No. of animals per sex per dose:

no data

Control animals:

yes, concurrent vehicle

Details on study design:

The treated areas of skin were examined daily for signs of dermal irritation and assessed according to the following scoring system:

erythema and eschar formation:
no erythema 0
slight erythema 1
well-defined erythema 2
moderate to severe erythema 3
severe erythema (beet redness) to slight eschar formation 4
(injuries in depth)

Oedema formation:
No oedema 0
slight oedema 1
well-defined oedema (area well defined by definite raising) 2
moderate oedema (raised approximately 1 mm) 3
severe oedema (raised more than 1 mm and extending 4
beyond the area of exposure).

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 other: g/Kg

Based on:

test mat.

Mortality:

There were no mortality or signs of toxicity.

Clinical signs:

other: Slight erythema was observed in one rat on the first three days following treatment.

Gross pathology:

Terminal autopsy findings were normal.

Other findings:

Control rats treated with the vehicle alone did not show any observable dermal reactions.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute median lethal percutaneous dose (LD50) to rats of Sanduvor pulver was found to be greater than 5.0 g/Kg bodyweight.

Executive summary:

An acute dermal toxicity study was conducted in male rats. The test item was prepared as a 40% suspension in aqueous gum tragacanth (0.5%) and administrated at a dosage volume of 12.5 ml/Kg bodyweight by spreading evenly over the prepared skin. There were no deaths in the study, and no evidence of systemic toxicities or local irritation. Based on the results, the acute dermal median lethal dose (LD50) in rats was determined to be greater than 5.0 g/Kg bodyweight.