Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 265-154-5 | CAS number: 64742-51-4 A complex combination of hydrocarbons obtained by treating a petroleum wax with hydrogen in the presence of a catalyst. It consists predominantly of straight chain paraffinic hydrocarbons having carbon numbers predominantly in the range of about C20 through C50.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2003-09-26 to 2003-12-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it followed OECD guideline No. 404 and followed Good Laboratory Practice.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 8002-74-2
- Cas Number:
- 8002-74-2
- IUPAC Name:
- 8002-74-2
- Reference substance name:
- paraffin wax
- IUPAC Name:
- paraffin wax
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): SARAWAX 50
- Substance type: paraffin wax
- Physical state: white waxy solid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 90 to 94%M N-alkanes, 10 to 6%M iso-alkanes
- Purity test date: not reported
- Lot/batch No.: 03/3361
- Expiration date of the lot/batch: 2006-09-01
- Stability under test conditions: stable for at least 96 hours in water vehicle
- Storage condition of test material: at room temperature in the dark
- Molecular weight (average Mn 360)
- 90 to 94% M N-alkanes, 10 to 6% M iso-alkanes
- Specific gravity 0.763 at 80 °C
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kilogram
- Housing: individually housed in cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.2 to 23.2°C
- Humidity (%): 49 to 75%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
IN-LIFE DATES: From: 2003-10-07 To: 2003-10-17
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: skin was wetted with 50% v/v ethanol/water solution before application of test material
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams of test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: flank
- % coverage: 2 x 3 centimetres
- Type of wrap if used: metalline patch, mounted on micropore tape, secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water was used to remove residual test substance
- Time after start of exposure: four hours
SCORING SYSTEM: Draize Method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slight erythema was observed at 1 hour in the skin areas of all three rabbits but resolved by 24 hours.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, paraffin wax is considered not irritating.
- Executive summary:
In a primary skin irritation study, the intact skin of three male New Zealand albino rabbits was exposed to 0.5 milligrams of paraffin wax under semi-occlusive conditions for 4 hours. Animals were observed for 72 hours, and skin irritation or corrosion was scored by the method of Draize at 1, 24, 48, and 72 hours. At the end of the 4 -hour test period, excess paraffin wax was removed with water. Slight erythema was observed at 1 hour in all three animals which was fully reversible by 24 hours. Therefore, under conditions of the study, paraffin wax is considered not irritating.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it is a well-documented study report and closely followed OECD Guideline No. 404.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)