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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:
weight of evidence
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:
1974
Report date:
1974

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:
- Principle of test: Draize method
- Parameters analysed: Irritation, corneal damage
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bismuth chloride oxide
EC Number:
232-122-7
EC Name:
Bismuth chloride oxide
Cas Number:
7787-59-9
Molecular formula:
BiClO
IUPAC Name:
chlorobismuthanone
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania
- Weight at study initiation: 2,8 - 3 kg

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 50%

Duration of treatment / exposure:
2 seconds, 4 seconds and 7 days (not washed)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 per group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, for 2 groups with lukewarm tap water
- Time after start of exposure: Irrigated 2 seconds and 4 seconds postinstillation

SCORING SYSTEM: Draize method but not described in detail in the report

TOOL USED TO ASSESS SCORE: Fluorescein for evidence of corneal damage

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals; Nonirrigated
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals; Irrigated 2 seconds postinstillation
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
3 animals: Irrigated 4 seconds postinstillation
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

In the OECD guideline 405 similar eye irritation test, the test substance (formulation of 50% in water) was tested for eye irritation in rabbits.

0.1 mL of the test substance was administrated to the left eye of 9 rabbits. The right eye served as control.

There were three groups with each three rabbits. The treated eyes 1) were not washed, 2) washed two seconds postinstillation, or 3) washed four seconds postinstillation with approximately 25 mL of lukewarm tap water.

Observations for eye injury and irritation were made at 24, 48, and 72 hours and at four and seven days and graded and scored according to the system of J. H. Draize. There were no signs of eye irritation in any animal throughout the entire seven day test period. Terminal fluorescein examination confirmed the absence of corneal damages in all treated eyes.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified