Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
The animals were identified via ear tattoo. They were held (singly) in stainless steel cages (floor area: 40 x 51 cm). The animals were housed in fulfly aiar-conditioned rooms with a temperature ranging from 20 - 24°C and a relative humidity between 30 - 70%. The light/dark rhythm was 12 hours dark and 12 h ours light. A standard rabbit diet (about 130 g/animal/day) and about 250 ml tap water/animal/day were offered. The acclimatization period was at least 8 days before the beginning of the study (same housing conditions as during the study).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
Single application to the conjunctival sac of the right eyelid; the test substance was not washed out.
Readings were done 1 h, 24 h, 48 h, 72 h, 8 d, 15 d and 21 d after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
2.2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 21 d

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information