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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 265-098-1 | CAS number: 64741-97-5 A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19 cSt at 40°C). It contains relatively few normal paraffins.
- 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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it is an acceptable, well-documented study report.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- skin was abraded; exposure was over 24 hours instead of 4 hours
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- 64742-53-6
- Cas Number:
- 64742-53-6
- IUPAC Name:
- 64742-53-6
- Reference substance name:
- Hydrotreated light naphthenic oil, insufficiently refined, IP346>3%
- IUPAC Name:
- Hydrotreated light naphthenic oil, insufficiently refined, IP346>3%
- Test material form:
- other: Oily liquid
- Details on test material:
- - Name of test material (as cited in study report): hydrotreated light naphthenic oil, CAS No. 64742-53-6
-Substance Type: Lubricant base oil (insufficiently refined, IP 346 > 3wt%)
- Physical state: Liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: range of 2,502 to 2,815 grams
- Housing: animals were housed individual in screen-bottom cages
- Diet: Purina Certified Rabbit Chow #5322 provided ad libitum
- Water: water provided ad libitum
- Acclimation period: fourteen days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24°C
- Humidity (%): 62 to 78%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 1984-09-05 To: 1984-10-11
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and shaved
- Vehicle:
- other: None - undiluted
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- Animals were observed for erythema and oedema after the 24 hour exposure period, at 72 and 96 hours, and 7 and 14 days.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: hair was clipped from the back and flank of each rabbit
- Type of wrap if used: occlusive, covered with a gauze patch and secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area was wiped clean with wet disposable towels
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24 and 72 hours
- Score:
- 5.4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.67
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.67
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.67
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.83
- Irritant / corrosive response data:
- The primary dermal irritation score was 5.4. Signs of erythema and oedema were seen at all across all observation periods, except day 14 day, at both the intact and abraded sites.
Any other information on results incl. tables
Average Irritation scores are given below:
ObservationPeriod |
Erythema |
OEdema |
Irritation Score |
||
Intact |
Abraded |
Intact |
Abraded |
||
24 hrs |
2.3 |
2.3 |
2.7 |
2.7 |
5.0 |
72 hrs |
3.0 |
3.0 |
2.5 |
3.0 |
5.8 |
96 hrs |
2.7 |
2.8 |
2.7 |
3.0 |
5.6 |
7 days |
1.3 |
2.2 |
0.8 |
1.7 |
3.0 |
14 days |
0 |
0 |
0 |
0 |
0 |
Primary dermal irritation index: 5.4
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is classified as a mild irritant by the study report.
- Executive summary:
In a primary dermal irritation study six male New Zealand White rabbits were dosed with 0.5 mL of hydrotreated light naphthenic oil on two areas of exposed skin, one shaved and one abraded. The treated area was then covered with an occlusive dressing. After 24 hours, the dressing was removed and the treated skin was wiped to remove any residue of test material. The degree of erythema and oedema was recorded according to the Draize scale. A second reading of skin responses was made at 72 hours and again at 96 hours, and 7 and 14 days.
Results of the 24 and 72-hour readings were used to determine the Primary Irritation Index. The primary dermal irritation score was 5.4. Signs of erythema and oedema were seen at all across all observation periods, except day 14 day, at both the intact and abraded sites. The mean erythema and oedema scores for the 24 to 72 hour period were 2.67 and 2.67 for intact skin. For abraded skin, the mean erythema and oedema scores for the 24 to 72 hour period were 2.67 and 2.82, repsectively, for abraded skin. This study was performed during 24 hours rather than 4 hours recommended by the current OECD guidelines. Consequently, the result from a shorter exposure time will likely not cause classification of the category. Lubricant base oils (IP 346 > 3 wt %) are not skin irritants based on a weight of evidence approach.
This study received a Klimisch score of 2 and is classified as reliable without restriction because it is an acceptable, well-documented study report.
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.