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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.

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