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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

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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: Report of a study using a standard test method and with full detail of individual animal results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Federal Register 29 (1964), section191.12
GLP compliance:
no
Remarks:
Pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
EC Number:
254-372-6
EC Name:
N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
Cas Number:
39236-46-9
Molecular formula:
C11H16N8O8
IUPAC Name:
N',N'''-methylenebis{1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea}
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Fine white powder

Test animals / tissue source

Species:
rabbit
Strain:
other: described as albino rabbits
Details on test animals or tissues and environmental conditions:
Further details not available.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
the lesser of 100 mg or 0.1 ml compacted volume.
Duration of treatment / exposure:
Applied and then scored after 24, 48 and 72h.
Observation period (in vivo):
24, 48 and 72h post-treatment.
Number of animals or in vitro replicates:
6
Details on study design:
Test substance placed into a cup formed by gently pulling the lower eye lid, then eyelids held together for one second. One eye/animal treated, the other serving as control.
Corneal, conjunctival and iridial reactions scored after 24, 48 and 72h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all 6 test animals
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Remarks on result:
other: No reactions seen
Irritation parameter:
iris score
Basis:
other: all 6 test animals
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Remarks on result:
other: No reactions seen
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
0.67
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
0.17
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: full recovery by this observation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
0.17
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48h and 72h
Score:
0
Max. score:
0
Reversibility:
other: full recovery by the 48h observation
Irritant / corrosive response data:
No corneal or iridial reactions were seen.
Transient conjunctival redness was seen in 4 test rabbits: mean score 24+48+72h across all 6 animals = 0.28, maximum score at any observation =1.
A single observation of chemosis was recorded (one animal, 24h only).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study only minor and transient conjunctival reactions were seen, following instillation of test substance into rabbit eyes.