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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: BASF test (Draize Test), similar to OECD 405; non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ephedrine hydrochloride
EC Number:
200-074-6
EC Name:
Ephedrine hydrochloride
Cas Number:
50-98-6
Molecular formula:
C10H15NO.ClH
IUPAC Name:
2-(methylamino)-1-phenylpropan-1-ol hydrochloride
Constituent 2
Reference substance name:
(-)-Ephedrin Hydrochlorid
IUPAC Name:
(-)-Ephedrin Hydrochlorid
Details on test material:
- name of the test substance: (-)-Ephedrin-Hydrochlorid
- substance number: 80/198
- Expiration date of the lot/batch: june 1982

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: irma Gaukler 6050 Offenbach / Main
- Weight at study initiation: mean weight males: 2.89 kg; mean weight females: 2.69 kg.
- Housing: in single cages
- Diet (ad libitum): Ovator Solikanin 4 MM; Muskator-Werke, 4000 Duesseldorf-1; about 130 g/day
- Water (ad libitum): 250 mL of aqua dest./day
- Acclimation period: about 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50-80
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
water
Controls:
other: The untreated eyes served as controls.
Amount / concentration applied:
Amount applied: 0.1 mL (about 34 mg of the test substance)
Duration of treatment / exposure:
8 days; no wash out of the test substance.
Observation period (in vivo):
8 days

Number of animals or in vitro replicates:
6 (5 males, 1 female)
Details on study design:
Comment: not rinsed
Scoring performed after 1; 24; 48; 72 hours and 8 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
other: animals #1, #2, #3, #4, #5, #6
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
other: Due to the low score, a full reversibility is expected within 21 days. However, observation time was only 8 days.
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
other: Due to the low score, a full reversibility is expected within 21 days. However, observation time was only 8 days.
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
other: Due to the low score, a full reversibility is expected within 21 days. However, observation time was only 8 days and a score of 1 was set at that day..
Remarks on result:
other: individual scores: 1 - 1 - 0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: induvidual scores: 1 - 0 - 0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
conjunctivae score
Basis:
animal: animals #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
3
Reversibility:
other: Due to the low score, a full reversibility is expected within 21 days. However, observation time was only 8 days.
Remarks on result:
other: individual scores: 2 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
other: animals #5 and #6
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 1 - 1
Irritation parameter:
chemosis score
Basis:
other: animals #1, #3, #4 and #6
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 0 - 0
Irritation parameter:
chemosis score
Basis:
animal: animals #2 and #5
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU