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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study (only 0.05 ml test substance tested; only 8-day observation period)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Principles of method if other than guideline:
BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): molybdat red V 15243
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: containing 60% Pb; no additional data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler (1 male and 1 female animals)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.35 kg (3.13 kg at the end) for the male animal, 2.85 kg (2.85 kg) for the female animal
- Diet (e.g. ad libitum): Ssniff
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of the same animal treated with 50mg talcum powder
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
Duration of treatment / exposure:
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 (if done): not washed

SCORING SYSTEM:
as described in OECD guideline 405

TOOL USED TO ASSESS SCORE: biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
cornea opacity
Basis:
mean
Time point:
other: 24-48-72 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-48-72 hour
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Based on the irreversibility of the observation the test substance not irritating according to the EU and GHS.
Other effects:
test substance coloration of the eyes was observed up to 3 hours after treatment with slight chemosis (score: 1 after 1 hour in one animal and after 3 hours in the second, but completely reversible after 3 and 24 hours respectively)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean scores calculated over all animals tested were below 1 for corneal opacity, below 1 for iris lesions, below 2 for redness of the conjunctivae and below 2 for edema formation and there were no individual animals with scores equal to the above values. Therefore, the test substance is considered to be not irritating to the eye of white Vienna rabbits according to EU- and GHS-criteria under the conditions of the study.