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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

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:
BASF-test, according to method described in Federal Register 38, No. 187, para. 1500.42, S. 27029, 1973-09-27.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4-dimethoxyphenethylamine
EC Number:
204-376-9
EC Name:
3,4-dimethoxyphenethylamine
Cas Number:
120-20-7
Molecular formula:
C10H15NO2
IUPAC Name:
2-(3,4-dimethoxyphenyl)ethanamine
Test material form:
liquid
Details on test material:
- name of substance: homoveratrylamin
- Purity: 98 %
- substance number: 78/836
- appearance: clear, yellowish, slightly viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- food: SSNIFF, Intermast
- mean weight at study initiation: 2.76 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
0.1 mL of the undiluted test item
Duration of treatment / exposure:
8 days, since no wash out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: cornea opacity (1-4); iritis (1-4); chemosis (1-3); conjunctivae redness (1-3).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
other: animal #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individaul scores: 1 - 1 - 1;
Irritation parameter:
cornea opacity score
Basis:
other: animal #1 and #3
Time point:
other: 24 - 48 - 72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 - 3 - 4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 - 3 - 3
Irritation parameter:
conjunctivae score
Basis:
other: animal #1, #2 and #3
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
chemosis score
Basis:
other: animal #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 - 2 - 2
Other effects:
- after 24 hours: scar formation (1 animal) and pyesis (1 animal).
- after 48 hours: scar formation (3 animals) and pyesis (3 animals).
- after 72 hours: scar formation (3 animals) and pyesis (3 animals).
- after 8 days: pyesis (two animals), scar formation (3 animals) and staphyloma formation (2 animals).

Any other information on results incl. tables

Time

Animal

Trübung

Iris

Rötung

Schwellung

Remarks

24 h

1

3

1

2

2

SC

2

3

1

2

2

S/sp

3

3

1

2

2

 

48 h

1

3

1

2

2

SC/S

2

3

1

2

2

SC/S

3

3

1

2

2

SC/S

72 h

1

4

1

2

2

SC/S

2

3

1

2

2

SC/S

3

4

1

2

2

SC/S

8 d

1

4

**

2

2

SC/S /ST

2

3

**

2

2

SC/S

3

3

1

2

2

SC/S /ST

S: suppuration

sp: sclera bulging

SC: scar

ST: staphyloma

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of this study, the test substance homoveratrylamine showed irreversible effects on the eyes.