Registration Dossier

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: post-observation period too short to judge reversibility of effects

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
publication
Title:
OECD SIDS 1,3-Dimethylurea (CAS: 96-31-1)
Author:
BASF AG
Year:
2003
Bibliographic source:
UNEP Publications

Materials and methods

Principles of method if other than guideline:
Method: other: Fed. Reg., 38, § 1500.42, (1973)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3-Dimethylurea (CAS: 96-31-1)
- Impurities (identity and concentrations): approx. 1.0 % Monomethylharnstoff, approx. 1.0 % Trimethylharnstoff, approx. 0.5 % water

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: M .GAUKLER, 6050 Offenbach
- Weight at study initiation: about 2.9kg - 3.1kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Concentration: 50 mg
Duration of treatment / exposure:
single treatment, not washed
Observation period (in vivo):
24, 48, 72 hours and after 8 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.1
Max. score:
4
Reversibility:
not fully reversible within: 8 days (one of 6 still score 1)
Remarks on result:
other: first study
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: first study
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: first study
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: first study
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: second test
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: second test
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.4
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: second test
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: second test

Any other information on results incl. tables

Results of the first study:
24 hours after instillation a slight redness (grade 1) in 6/6 animals, and slight lacrimation in 4/6 animals were observed. Erythema (grade 1) persisted until 72 hours after instillation, but was completely reversible within 8 days. Slight lacrimation was observed in 3/6 animals at 48 hours, and had completely resolved at 72 hours. In 2 out of 6 animals corneal opacity (grade 1, covering between 50 and 75% of area) was noted at 24, 48 and 72 hours. The corneal effect was still present (in same degree) in one of these animals at the end of the study on day 8.
 

Results of the second study:
24 hours after instillation slight to marked redness (grades 1 and 2) in
 6/6 animals, slight edema (grade 1) in 2, and slight lacrimation in 6/6 animals was observed. Erythema persisted (with decreasing severity) until 72 hours after instillation in all animals, and was still present in three animals on day 8 (grade 1). Lacrimation was observed in 6/6 animals at 48 hours, and in 3/6 at 72 hours, and had completely subsided on day 8. Corneal opacity (grade 1, patchy, iris clearly visible) was noted only in one single animal at 72 hours after instillation; no opacities were found at the end of the study (day 8).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information