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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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.