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Diss Factsheets
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EC number: 292-642-5 | CAS number: 90669-48-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 26 November 2001 to 30 November 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, conducted to a valid guideline and was performed under GLP conditions. Since the study was conducted with the read across substance, hydrocarbon waxes (petroleum), oxidised, it has been assigned a reliability score of 2. Read across from this substance is justified on the basis of its similar physical and chemical properties to those of the registered substance. Furthermore, it has a very similar chemical structure; the registered substance is an esterified form of the read across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbon waxes (petroleum), oxidized
- EC Number:
- 265-205-1
- EC Name:
- Hydrocarbon waxes (petroleum), oxidized
- Cas Number:
- 64743-00-6
- Molecular formula:
- Not applicable to a UVCB substance
- IUPAC Name:
- Hydrocarbon waxes (petroleum), oxidized
- Test material form:
- other: greasy solid
- Details on test material:
- - Physical appearance: Light brown semi-solid
- Storage: Room temperature and humidity
- Acid number: 24-40
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA, USA
- Date received: 31 October 2001
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Individually in suspended wire cages
- Diet: Fresh Purina Rabbit Chow, Diet # 5321, supplied by Purina Mills, Inc. (provided daily)
- Water: ad libitum
- Quarantine period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled
- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/rabbit. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Up to 72 hours
- Number of animals:
- Three in total, two females and one male
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The torso was wrapped with plastic
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with distilled water
- Time after start of exposure: Immediately after patch removal
OBSERVATIONS
- Time points: 60 minutes, 24, 48 and 72 hours
- Dermal reaction, ulceration, necrosis or any evidence of tissues destruction were recorded at each time point
- General health was recorded at each time point
- Body weights were recorded before exposure and at termination
SCORING SYSTEM: Erythema and edema were scored according to the Draize scale (1977), which can be seen in table 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Other effects:
- - No abnormal physical signs were noted during the observation period.
- One animal lost body weight, all other weight changes were normal.
Any other information on results incl. tables
Table 2. Results of Observed Dermal Reactions
Observation |
Animal and Sex |
Time after patch removal |
Average Score of 24, 48 and 72 hrs. |
|||
60 (mins) |
24 (hrs) |
48 (hrs) |
72 (hrs) |
|||
Erythema Score |
Female No. 1 |
2 |
1 |
0 |
0 |
0.33 |
Female No. 2 |
1 |
1 |
0 |
0 |
||
Male No. 3 |
1 |
1 |
0 |
0 |
||
Edema Score |
Female No. 1 |
0 |
0 |
0 |
0 |
0.11 |
Female No. 2 |
0 |
0 |
0 |
0 |
||
Male No. 3 |
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study report concludes that the test material is a dermal irritant. However, under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified" according to EU criteria.
- Executive summary:
In a GLP compliant dermal irritation study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from observations at 24, 48 and 72, were scored according to the Draize (1977) scale, and recorded. The mean score for erythema was 0.33 while the mean score for edema was 0.11; all observed signs of irritation completely reversed within 48 hours. Under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified" according to EU criteria.
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