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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol
Cas Number:
59-42-7
Molecular formula:
C9-H13-N-O2
IUPAC Name:
3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol
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.