Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to OECD 405 guideline study (2002) with acceptable restrictions [dose not exactly specified (OECD: volume of 0.1 ml); 2 animals are used (OECD: 3); examination using fluorescein (OECD: no use of fluorescein)] (For read-across justification refer to section 13)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
BASF-TEST: Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. In studies with solids, talcum powder was used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.39; 3.15 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: talcum treated eye of the same animal
Amount / concentration applied:
- Amount applied: a sharp spoon (probably approximately 50 mg)
Duration of treatment / exposure:
- substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done

READING TIME POINTS
10 min, 1 h, 3 h, 24 h, 48 h, 72 h, 6 days and 8 days after application; however the data on the 48 h, 72 h and 6 days reading of animal 2 are not reported.

READING TIME POINTS USED FOR ASSESSMENT
24, 48 and 72 h for animal 1; 24 h for animal 2

SCORING SYSTEM:
For the evaluation the BASF scores given in the raw data were converted to Draize scores

TOOL USED TO ASSESS SCORE: fluorescein

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
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 - 72 h for animal 1; 24 h for animal 2
Score:
0.5
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Both animals showed some redness of the conjunctivae (score 1), 24 h after application of the TS. The same effect was observed in the talcum powder treated eye. This effect was fully reversible 48 h in animal 1 and at least within 8 days in animal 2.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information