Registration Dossier
Registration Dossier
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EC number: 270-348-8 | CAS number: 68425-34-3
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting 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:
- 1 972
- Report date:
- 1972
- 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
- Study type:
- study with volunteers
- Endpoint addressed:
- skin 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:
- 100% Paraffin Wax (For Petrolatum (Non-carcinogenic Feed-stock))
- IUPAC Name:
- 100% Paraffin Wax (For Petrolatum (Non-carcinogenic Feed-stock))
- Details on test material:
- Read Across to Paraffin and Hydrocarbon Waxes
-Test Substance: 100% paraffin wax
Constituent 1
Method
- Type of population:
- general
- Subjects:
- -20 human subjects
- Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- A sample of 100% paraffin was patch-tested on 20 people per sample for a period of 24 hours.
Results and discussion
- Clinical signs:
- No observations of clinical toxicity reported
- Outcome of incidence:
- The test sample caused barely perceptible erythema in one person. All others were negative for irritation.
Applicant's summary and conclusion
- Conclusions:
- The sample caused barely perceptible erythema in one of twenty people tested and is considered to be not irritating to human skin.
- Executive summary:
Read across justification
No dermal irritation studies have been reported for petrolatum (non-carcinogenic feed-stock), but data have been reported for paraffin and hydrocarbon waxes, materials similar to constituents of petrolatum (non-carcinogenic feed-stock).
In a primary dermal irritation study, 20 human volunteers were treated with a sample of 100% paraffin wax in a 24-hour patch test. The test sample caused barely perceptible erythema in one person. The test material is considered 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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