Desmedipham

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-10-28 to 1991-03-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

Desmedipham

EC Number:

237-198-5

EC Name:

Desmedipham

Cas Number:

13684-56-5

Molecular formula:

C16 H16 N2 O4

IUPAC Name:

ethyl 3´-phenylcarbamoyloxycarbanilate

Test material form:

solid: particulate/powder

Details on test material:

The test material is Desmedipham but the purity has not been specified.

Specific details on test material used for the study:

The test material, a white powder, was stored in the dark under ambient conditions.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adults.
- Weight at study initiation: Not provided.
- Housing: individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Standard Rabbit Diet, ad libitum.
- Water: ad libitum.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 18
- Mean Relative Humidity (%): 67
- Air changes (per hr): Not provided.
- Photoperiod: 12 h light/dark cycle (light hours 0700-1900 h).

The rabbits were uniquely identified within the study by means of an indelible number on the inner surface of the ear.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

Approximately 24 h before treatment. Care was taken to avoid abrading the skin.

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g, moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk of each rabbit.
- % coverage: Not provided.
- Type of wrap if used: The patch was then covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 h after patch removal

SCORING SYSTEM:
- Method of calculation: OECD Recommended Scoring System:

1- 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

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table 1:
Desmedipham: Acute Dermal Irritation Test in Rabbits Reaction Scores

Animal/sex	Erythema				Oedema
	1 h	12 h	24 h	72 h	1 h	12 h	24 h	72 h
1/male	0	0	0	0	0	0	0	0
2/male	0	0	0	0	0	0	0	0
3/male	0	0	0	0	0	0	0	0

h = Hours after patch removal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Desmedipham is non-irritant to rabbit skin and does not require classification for skin irritation in any category according to the CLP criteria.

Executive summary:

The acute dermal irritation potential of Desmedipham, was investigated in 3 New Zealand White rabbits. No skin reactions were noted following a 4 hour semi-occlusive application of Desmedipham to rabbit skin. Desmedipham is non-irritant to rabbit skin and does not require classification for skin irritation in any category according to the CLP criteria.