Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): AR-FD 26 ( phase X )
- Physical state: powder
- Lot/batch No.: 01010

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Diet (e.g. ad libitum): Conventional feeding


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 : 12

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/0.1g
A single dose of 0,1 g of was instilled onto the everted lower lid ( conjunctiva
sac) of one eye of each animal
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: all animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
other: 1, 24, 48, 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: all animals
Time point:
other: 1 h and 24 h
Score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal: all animals
Time point:
other: 48 h and 72 h
Score:
0
Irritation parameter:
other: Iris Inflammation
Basis:
animal: all animals
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
other: Iris infalmmation
Basis:
animal: all animals
Time point:
other: 24, 48 and 72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Conclusion: According to the supplement of the Official Billefing of Spain BOE
num. 133 ( Monday, June fifth 1995), the assayed product is classified as:
Not important eyes lesion cause