Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 21
Author:
OECD
Year:
2007
Bibliographic source:
OECD SIDS

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Principles of method if other than guideline:
The procedure used is based, but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study".
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 65'023/L
- Physical state: powder
- Analytical purity: active substance content 83%,
- Lot/batch No.: EN 20
- Stability under test conditions: not determined

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single exposure; in 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was washed out
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 ml of sterile physiological saline.
- Time after start of exposure: In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
rinsed and unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no reactions
Irritation parameter:
iris score
Basis:
mean
Remarks:
rinsed and unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no reactions
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
rinsed eyes
Time point:
other: 24 h - 48 h - 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Findings animal 1/2/3 (undiluted test substance, eyes not washed out):

 Time   Opacity Iritis  Erythema  Chemosis                  
24 h 0/0/0 0/0/0 0/1/1 1/0/0                  
48 h

0/0/0

 0/0/0 0/1/0 0/0/0                  
72 h 0/0/0  0/0/0 0/0/0 0/0/0                  
 7 d 0/0/0  0/0/0 0/0/0 0/0/0                  
 Mean: 24h - 48h - 72h 0/0/0  0/0/0 0/0.7/0.3 0.3/0/0                  

Findings animal 4/5/6 (undiluted test substance, eyes washed out):

 Time   Opacity Iritis    Erythema Chemosis                  
24 h 0/0/0  0/0/0 1/0/0 0/0/1                  
48 h

0/0/0

 0/0/0 0/0/0 0/0/0                  
72 h 0/0/0  0/0/0 0/0/0 0/0/0                  
 7 d 0/0/0  0/0/0 0/0/0 0/0/0                  
 Mean: 24h - 48h - 72h 0/0/0 0/0/0 0.3/0/0 0/0/0.3                  

FAT 65'023/L was found to cause mild irritation when applied to the rabbit eye mucosa.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant to eyes.