Registration Dossier
Registration Dossier
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EC number: 232-455-8 | CAS number: 8042-47-5 A highly refined petroleum mineral oil consisting of a complex combination of hydrocarbons obtained from the intensive treatment of a petroleum fraction with sulfuric acid and oleum, or by hydrogenation, or by a combination of hydrogenation and acid treatment. Additional washing and treating steps may be included in the processing operation. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C50.
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:
- 1984-10-13 to 1984-10-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure duration was 24 hours instead of 4 hours
- GLP compliance:
- yes
Test material
- Reference substance name:
- 8042-47-5
- Cas Number:
- 8042-47-5
- IUPAC Name:
- 8042-47-5
- Reference substance name:
- Highly refined base oil
- IUPAC Name:
- Highly refined base oil
- Test material form:
- other: Oily liquid
- Details on test material:
- - Name of test material (as cited in study report): white mineral oil [F-52-01; ARCOprime 70]
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): see Fig. N/A
- Substance type: petroleum hydrocarbons
- Physical state: transparent colourless liquid
- Analytical purity: 100% petroleum hydrocarbons
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 769
- Expiration date of the lot/batch: September 1989
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: approximately 5 years
- Storage condition of test material: stored in temperature-monitored room (10 to 27 degrees Celsius)
- Density 0.8433 g/ml
- Flash Point °F: 355
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: Alpine Laboratory Rabbits
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 2.1 to 2.3 kilograms
- Housing: individually housed in stainless steel cages with screen floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 and 24 degrees Celsius
- Humidity (%): 28 to 57%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: From: 1984-10-29 To: 1984-10-16
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch squares on the lateral sides of the spine
- % coverage: 20%
- Type of wrap if used: gauze pads stabilized with hypoallergenic tape to which a dental dam was applied.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin wiped to removed test substance after exposure
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- At the 24 and 72 hour observation time points erythema and oedema scores were 0.0 for all sites.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean erythema and edema scores of Highly refined base oil under the conditions of this study are both 0. Therefore, the test material is classified as not irritating.
- Executive summary:
In a primary dermal irritation study,white rabbits (6 males) were dermally exposed to 0.5 mL of undiluted Highly refined base oil for 24 hours occlusively to 2 abraded and 2 unabraded test sites flanking the spine. Animals were then observed for 24 and 72 hours. Irritation was scored by the method of Draize (1959).
At the 24 and 72 hour observation time points erythema and edema scores were 0.0 for all sites. In this study, Highly refined base oil is not a dermal irritant based on the mean erythema and oedema scores of 0.0.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it is carried out according to or similar to guideline study OECD TG 404.
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