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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported study performed under GLP and using a standard test method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
EC Number:
278-928-2
EC Name:
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
Cas Number:
78491-02-8
Molecular formula:
C8H14N4O7
IUPAC Name:
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Bodyweight 2.2-2.6 kg and checked for absence of corneal, iridial or conjunctival abnormalities pre-test.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
67 mg (0.1 ml equivalent)
Duration of treatment / exposure:
3 rabbits: no removal of test substance up to 14 days post-treatment.
1 rabbit: treated eye washed with distilled water 30 seconds after treatment.
Observation period (in vivo):
Up to day 14 post-treatment.
Number of animals or in vitro replicates:
3 + 1
Details on study design:
One eye treated/animal: untreated eyes served as controls.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
: corneal opacity
Basis:
animal #1
Remarks:
mean score
Time point:
other: Across 24, 48, and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
cornea opacity score
Remarks:
: corneal opacity
Basis:
animal #2
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
cornea opacity score
Remarks:
: corneal opacity
Basis:
animal #3
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
0
Max. score:
0
Remarks on result:
other: Score 0 also at 1h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 2 also at 1h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also score 2 at 1h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Score 3 at 1h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also score 2 at 1h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
other: Across 24, 48 and 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also score 2 at 1h
Irritant / corrosive response data:
Iridial changes were less marked that those tabulated above:
- animal 1, score 1 at 24h only
- animal 2, score 1 at 48 and 72h only
- animal 3, score 0 only.

In the one additional animal eyewashed 30 seconds after treatment, no corneal or iridial changes were observed but conjunctival redness and discharge scores were 2 up to 72h (fully recovered by Day 14).

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, eye irritation was evident. All lesions were reversible, but the responses were sufficient to trigger classification under the CLP Regulation.