Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study performed according to internationally accepted method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Study was performed to evaluate the potential irritant effects of copper slag on the mucous membranes (eyes) based on EU B5 method - Acute toxicity - eye irritation. The test substance was applied in a single dose in an animal's eye using the other eye as control.
GLP compliance:
no
Remarks:
other quality assurance

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Rabbit healthy adult male albino
The diet was standard for this type of animal. The animal house temperature was maintained at 20 + / - 2C, the relative humidity was between 30-70% and photoperiod was 12/12 hours light / dark.

Test system

Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Time point:
other: 72h
Score:
0
Remarks on result:
other: No ulceration or opacity
Irritation parameter:
iris score
Time point:
other: 72h
Score:
0
Remarks on result:
other: Normal
Irritation parameter:
conjunctivae score
Time point:
other: 72h
Score:
0
Remarks on result:
other: Normal blood vessels
Irritation parameter:
chemosis score
Time point:
other: 72h
Score:
0
Remarks on result:
other: No swelling

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Good quality study. the sample is not eye irrutant.
Executive summary:

Study was performed to evaluate the potential irritant effects of copper slag on the mucous membranes (eyes) based on EU B5 method - Acute toxicity - eye irritation

Based on the results, copper slag is not eye irritant.