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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Benzyl(3-hydroxyphenacyl)methylammonium chloride
EC Number:
276-017-4
EC Name:
Benzyl(3-hydroxyphenacyl)methylammonium chloride
Cas Number:
71786-67-9
Molecular formula:
C16H17NO2.ClH
IUPAC Name:
benzyl(3-hydroxyphenacyl)methylammonium chloride
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Benzyladrianon HCl
- Physical state: solid
- Analytical purity: 99.07 %
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. K. Thomae , Biberach/Riß
- Age at study initiation: ca. 8 months
- Weight at study initiation: ca. 2 kg

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
Observation period (in vivo):
22 d
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 101
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 120 h
Irritation parameter:
cornea opacity score
Basis:
animal: 102
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal: 151
Time point:
other: 1 -21 d
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal: 152
Time point:
other: 1h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 17 d
Irritation parameter:
iris score
Basis:
animal: 101
Time point:
other: 1h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
animal: 102
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal: 151
Time point:
other: 1 - 21 d
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
animal: 152
Time point:
other: 1 d - 21 d
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 101
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 120 h
Irritation parameter:
conjunctivae score
Basis:
animal: 102
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Irritation parameter:
conjunctivae score
Basis:
animal: 151
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 9 d
Irritation parameter:
conjunctivae score
Basis:
animal: 152
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 12 d
Irritation parameter:
chemosis score
Basis:
animal:
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 102
Time point:
other: 24 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal: 151
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: 152
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 6 d

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
Die Substanz Benzyladrianon HCl wird aufgrund der erhobenen Befunde als - schleimhautunverträglich - beurteilt.
Executive summary:

Die verabreichung von 20 mg Benzyladrianon HCl in den Konjunktivalsack des Auges von Himalayam-Kanninchen verursachte bei allen Kanninchen Veränderungen an der Cornea und Conjunktiva, bei einem Tier auch an der Iris. Die Veränderungen waren gering bis hochgradig, bei einem Tier nach 5 Tagen, bei einem anderen Tier nach 9 Tagen und bei einem anderen Tier nach 17 Tagen zurückgebildet. Bei einem Tier waren die Käsionen innerhalb des 21 -tätgigen Nachbeobachtungszeit nicht reversible.