Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae , Biberach/Riß
- Age at study initiation: ca. 8 months
- Weight at study initiation: ca. 2 kg
- Housing: Individually housed
- Diet (e.g. ad libitum): Rabbit breeding feed Fa. Altromin
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 101, 102, 151
Time point:
other: 1 hour - 7 days
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
animal: all animals
Time point:
other: 1 hour - 7 days
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal: 152
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: 101, 151
Time point:
other: 1 h - 6 days
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 102
Time point:
other: 1 - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 96 h
Irritation parameter:
conjunctivae score
Basis:
animal: 152
Time point:
other: 1 - 24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 152
Time point:
other: 48h - 6 days
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
other: 1 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 101, 102, 152
Time point:
other: 24 - 48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 151
Time point:
other: 24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 151
Time point:
other: 48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In conclusion, according to the Globally Harmonized Classification System, (-)-Phenylephrinbase was non-irritating / non-corrosive to the eyes of
the rabbits.