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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 from supporting substance (structural analogue or surrogate)
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 for cross-reference:
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
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

Constituent 1
Reference substance name:
most likely 8002-74-2
IUPAC Name:
most likely 8002-74-2
Constituent 2
Reference substance name:
50% paraffin wax
IUPAC Name:
50% paraffin wax
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:

Read across justification

No eye irritation studies have been reported for petrolatum (non-carcinogenic feed-stock), but data have been reported for the principal constituents of these petrolatums, as well as paraffin and hydrocarbon waxes which are similar to petrolatum constituents.

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.

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