Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-30 - 2008-07-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Approximately 24 hours before application both eyes of rabbits were examined to remove animals with eye irritation, ocular defects or corneal injury.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes were examined at 1. 24, 48 and 72 hours after application, then Ix daily. After recording the observations at 24 hours, the eyes of rabbit were examined with the aid of fluorescein and the ophthalmoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination.
Number of animals or in vitro replicates:
1 male, two females
Details on study design:
The test substance (0.1 ml) was placed in the conjunctival sac of one eye of animal after gently pulling the lower lid away from the ball. After application the lids were gently held together for about one second to prevent loss of the test substance. At 24 hours after application the eye was irrigated which water.

Untreated eye (on the right side) served as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Evaluation of results after single application demonstrated that the test substance, Weikoform (Urea, reaction products with formaldehyde), is not irritating for eye of rabbit.
Executive summary:

The test substance. Weikoform (Urea, reaction products with formaldehyde), was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed). The test was performed according to the EU Method B.5 Acute Toxicity: Eye Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142. 2008. The test was performed initially using one animal. Because corrosive effect was not observed in initial test, negative response was confirmed using two additional animals. The following changes were observed on eye of animals at 1 hour after application in all animals: conjunctivae - some blood vessels hyperaemie (injected). At 24, 48 and 72 hours after application no signs of eye irritation were observed. No clinical signs of systemic intoxication were detected. Examination of eye irritation after single application demonstrated, that the test substance, Weikoform (Urea, reaction products with formaldehyde), is not irritating for eye of rabbit.