Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (partly limited documentation; 50 μl instead of 100 μl test substance instilled). Study sufficient for evaluation of this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triphenylphosphinoxid
Purity: pure, p.a.

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.96 - 3.12 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: approx. 50 mg of talcum in the other eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): pure
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Animal  Reading  Opacity Iritis Redness Chemosis Comment
1 1 h 0 0 1 0 substance residues
2 1 h 0 0 1 0 substance residues
1 3 h 0 0 1 0  
2 3 h 0 0 1 0  
1 24 h 0 0 1 0  
2 24 h 0 0 1 0  
1 48 h 0 0 1 0  
2 48 h 0 0 0 0  
1 72 h 0 0 1 0  
2 72 h 0 0 0 0  
1 4 d 0 0 0 0  
2 4 d 0 0 0 0  
1 7 d 0 0 1 0  
2 7 d 0 0 0 0  
1 8 d 0 0 0 0  
2 8 d 0 0 0 0  
1 24 - 72 h 0.00 0.00 1.00 0.00  
2 24 - 72 h 0.00 0.00 0.33 0.00  
mean 24 - 72 h 0.00 0.00 0.67 0.00  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information