Paraffin waxes (petroleum), hydrotreated

Eye irritation

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 for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

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

Test material information

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

Results

Results 1

Irritation parameter:

other: irritation observation

Time point:

other: 3 days

Remarks on result:

other: no irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable because of methodological limitations

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable because of methodological limitations

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable because of methodological limitations

Results 5

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.