Tetrahydro-1,3-dimethyl-1H-pyrimidin-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: well-documented study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one

EC Number:

230-625-6

EC Name:

Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one

Cas Number:

7226-23-5

Molecular formula:

C6H12N2O

IUPAC Name:

tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one

Test material form:

other: liquid

Details on test material:

Name of the test substance used in the study report: N,N'-Dimethylpropylenharnstoff

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

The animal(s) were held in stainless steel cages (floor area 40 x 51 cm). Identification of the animal(s) via ear tattoo. The animals were housedin fully air-conditioned rooms with a temperature in the range of 20 - 24°C and a relative humidity of 30 - 70%. The light/dark rhythm was 12 h light and 12 h darkness. A standardized rabbit diet (about 130 g per day) and about 250 ml tap water were offered.
Acclimatization period: At least 8 days before the beginning of the study (with the same housing conditions as during the study).
Clipping of the fur: At least 15 hours before the start of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

8 days (first test) or 72 hours (second and third test discontinued after 72 hours because no irritation could be observed at that time)

Number of animals:

6 (2 males, 4 females)

Details on study design:

Application site: upper third of the back or flank
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
readings: 30 - 60 min after removal of the test patches and 24, 48, 72 h and 8 d after the start of application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.8

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a study based on OECD 404 performed under non-GLP conditions, no edema was observed in 6 animals after 4-h semiocclusive exposure. Transient erythema was recorded in single animals, which led to a mean score of 0.8. Thus, the test substance is not irritating.