N,N''-propane-1,3-diylbis[N'-octadecylurea]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted in a contract research organization according to internationally accepted technical guidelines then at force, but without QA-statement. The study is scientifically valid and, despite limited documentation, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(of 1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Appraisal of Chemicals in Food, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States.

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.0 kg (average weight)
- Housing: individual cages
- Diet: standard laboratory diet for rabbits, Altromin, Lage, Germany)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2°C
- Humidity (%):50-60
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

5

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2 (gauze patches of 2.5 x 2.5 cm, fixed with adhesive plaster)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

TIME POINTS OF SKIN EVALUATION
- 1, 24, 48 and 72 h and 7 days post patch removal

SCORING SYSTEM:
According to Draize 1959 (“Dermal toxicity,” Appraisal of Chemicals in Food, Drugs and Cosmetics. The Association of Food and Drug Officials of the United States):
Erythema and formation of scabs:
Score 0: No erythema
Score 1: Slight erythema (scarcely visible)
Score 2: Erythema clearly visible
Score 3: Moderate to significant erythema
Score 4: Severe erythema (red purple) with formation of slight scabs (deep lesions)

Formation of oedema:
Score 0: No oedema
Score 1: Very slight oedema (scarcely visible)
Score 2: Slight oedema (well defined outlines, swelling apparent)
Score 3: Moderate oedema (thickness about 1 mm)
Score 4: Severe oedema (thickness more than 1 mm and area larger than the treated skin square)

Only differences from controls were considered to be positive reactions.

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

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

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no effects

Other effects:

No effects on mortality or clinical signs were reported.

Any other information on results incl. tables

Scoring of Erythema and Oedema Formation

Time point	1 h					24 h					48 h					72 h					7 d
Animal No	1	2	3	4	5	1	2	3	4	5	1	2	3	4	5	1	2	3	4	5	1	2	3	4	5
Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present experiment the test material was found to cause no irritation when applied to intact rabbit skin.