6-methyl-2-oxoperhydropyrimidin-4-ylurea

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study predates the OECD test guidelines and GLP. However, the study meets basic scientific principles with acceptable restrictions when compared to current standards (limited documentation, substance tested only as 50% dilution, observation/reading only at 24 hours and 8 days, only 2 animals tested). The study is a read-across from a structural analogue substance (CAS 6104-30-9).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Principles of method if other than guideline:

The test substance was applied substance as 50% dilution for 20 hours under occlusive conditions. Observation/reading was performed only at 24 hours and 8 days and only 2 animals were tested.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N''-(isobutylidene)diurea

EC Number:

228-055-8

EC Name:

N,N''-(isobutylidene)diurea

Cas Number:

6104-30-9

IUPAC Name:

N,N''-(2-methylpropane-1,1-diyl)diurea

Test material form:

other: aqueous preparation

Details on test material:

- Analytical purity: ca. 90-96%
- Impurities (identity and concentrations): 0-3% urea, 2% potassium sulfate

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: approximately 2.8 kg
- sex: male

No further data are given in the study report.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g
- Concentration (if solution): 50% aqueous preparation

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

over both tested animals

Time point:

other: mean over 24, 48, and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: No signs of irritation were observed.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

over both animals

Time point:

other: mean over 24, 48, and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: Nno signs of irritation were observed.

Other effects:

- Systemic toxicity: No mortality occurred. There were no signs of clinical toxicity from the dermal exposure.
- Irritation score: No skin findings were observed at any time
- Summary: Occlusive application for 20 h to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified