Perhydropyrimidin-2-one

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: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

BASF-TEST: Before OECD guideline 404 was established, skin irritation was tested using an internal method. White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5, 15 min and 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid or powdered and moistened test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed 3 days and skin changes were recorded on working days.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Propyleneurea

IUPAC Name:

Propyleneurea

Details on test material:

- Name of test material (as cited in study report): Propyleneurea
- Physical state: solid
- Purity: 97%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.0; 2.6 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

- Amount applied: unspecified (an application site of 2.5 cm x 2.5 cm was covered with the moistened test substance)
- The TS was moistened with water (80% TS in water)

Duration of treatment / exposure:

Dorsal skin: 1, 5, 15 min
Dorsal skin: 20 h
Ear: 20 h

Observation period:

7-8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: once with 100% Lutrol and additionally with 50% Lutrol in water
- Time after start of exposure: 1, 5 or 15 minutes, or 20 h

READING TIME POINTS USED FOR ASSESSMENT
24, 48 and 72 h after application

SCORING SYSTEM:
- For the evaluation the BASF scores given in the raw data were converted to Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: 20 h occlusive exposure

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: 20 h occlusive exposure

Irritant / corrosive response data:

- no corrosive/irritant effects after 20 h exposure of dorsal skin
- 1 - 15 min exposure of dorsal skin did also cause no edema or erythema

Other effects:

- no effects on the ear skin

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the conditions of this study the TS was assessed to be not irritating to the skin.