Registration Dossier

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: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: Acryloxibutylchlorformiat
- Purity: ca. 75%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
A young adult female animal with a body weight of 3.81 kg was used.
Cage (type: stainless steel wire mesh cages with grating, floor area 3000 cm2). The animal was identified via ear tattoo.
The animal was housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
The animal was offered a standardized animal laboratory diet (about 130 g/day) as well as tap water (about 250 ml/day).
Acclimatization period: at least one week

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
1
Details on study design:
Both eyes of the animal were examined before instillation of thetes substance for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study.
Weight determination: shortly before instillation
Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d, 15 d, 21 d
A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2.3
Max. score:
3
Reversibility:
not reversible
Irritant / corrosive response data:
Corneal opacity grade 2 at study termination.

Applicant's summary and conclusion