Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 265-145-6 | CAS number: 64742-43-4 A complex combination of hydrocarbons obtained by treatment of a petroleum wax fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of straight chain saturated hydrocarbons having carbon numbers in the range of C20 through C50.
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
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of fossil and synthetic waxes
- Author:
- Elder, R.L.
- Year:
- 1 984
- 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
- Reference substance name:
- most likely 8002-74-2
- IUPAC Name:
- most likely 8002-74-2
- 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
Constituent 1
Constituent 2
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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