Registration Dossier

Diss Factsheets

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: Comparable to guideline study with acceptable restrictions. Lack of details on test material. Observation period only 15 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test material; observation period only 15 days
GLP compliance:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Storage conditions: no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: 3.5 kg (males) and 3.6 kg (females)
- Housing: animals were housed individually in stainless steel cages with shelves
- Diet: Ovator Solikanin 4 mm (Muskator-Werke, Düsseldorf, Germany), 130 g/d for each animal
- Water: VE water (tap water at the weekend), 250 mL/d for each animal
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
15 days:
Reading time points: 1, 24, 48, 72 h and 8 and 15 days
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 15 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Severe and irreversible effects on the eyes in form of eye scaring in all 3 animals and cornea detachment in one animal was observed during the study.
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Slightly to significantly increased secretion was observed in all animals after 24, 48 and 72 h, which was not (fully) reversible within the 15-day observation period.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye Dam. 1, H318
DSD: Xi, R41