Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
ca. 55% active substance (moist; water)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Number of animals or in vitro replicates:
1 male
2 females

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
1.67

Any other information on results incl. tables

The primary irritation potential of the test article was investigated by instillation of 0.1 g into

one eye of each of three young adult New Zealand White rabbits. The treated eyes were not

rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48

and 72 hours after test article application. The scores of each animal at the following reading

times (24,48 and 72 hours) were used in calculating the respective mean values for each type

of lesion.

The primary irritation score was calculated by totalling the individual cumulative scores at 24,

48 and 72 hours and then dividing the resulting total by the number of data points. The

primary irritation score was 1.67 (max. 13). Moderate reddening (including hyperemia of the

scleral blood vessels) and slight swelling of the conjunctivae, as well as slight watery

discharge were observed in all animals 24 hours after treatment. All signs of irritation were

reversible after 72 hours.

No staining of the treated eyes by the test article was observed.

No corrosion was observed at any of the measuring intervals.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of

April 27, 1993), FAT 93'463/A is considered to be "not irritating" to the eye.

Applicant's summary and conclusion