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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions. The study is an acceptable, well-documented study report that followed sound scientific principles.
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980
Reference Type:
publication
Title:
Final report on the safety assessment of fossil and synthetic waxes
Author:
Elder, R.L.
Year:
1984
Bibliographic source:
Journal of the American College of Toxicology 3(3):43-99

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The method did not strictly follow the guideline but is deemed appropriate as utilized in this report.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Test Substance: 50% Paraffin in petrolatum
- Melting point 126-145 °F in CFTA summary report
- Melting point 43-65 °C in publication (Table 10)
- Specific gravity 0.880 - 0.915

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
albino rabbits

Test system

Vehicle:
other: petrolatum
Controls:
not specified
Amount / concentration applied:
Concentration: 50 %
Amount applied: 0.1 ml
Not rinsed
Duration of treatment / exposure:
No data reported.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: irritation observation
Time point:
other: 3 days
Remarks on result:
other: no irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable because of methodological limitations
Irritant / corrosive response data:
No irritation was observed.
Other effects:
No data reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to the eye.
Executive summary:

In an acute eye irritation test, 0.1 millilitres of a 50% paraffin wax in petrolatum solution was instilled into the eyes of six albino rabbits without rinse. The test material was not irritating.

This study received a Klimisch score of 2 and is classified as reliable with restrictions. The study is an acceptable, well-documented study report that followed sound scientific principles.