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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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, only 2 animals tested, only 50 µL applicated). 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 as a single instillation (50 µL) as powder, the substance was not washed out, only 2 rabbits were used
GLP compliance:
no

Test material

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:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Analytical purity: ca. 90-96%
- Impurities (identity and concentrations): 0-3% urea, 2% potassium sulfate

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: treated with talcum powder
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 µL (50 mm³)
Duration of treatment / exposure:
single instillation of the test substance as powder, the substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none, substance not washed out

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of both animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of both animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of both animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48, and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The maximal score was 1 at the 24 h reading time point.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The treatment led to slight redness. All findings were reversible after 8 days of observation period. The control eyes which were treated with talcum powder did show the same reactions.

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