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Diss Factsheets
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EC number: 308-132-3 | CAS number: 97862-82-3
- 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://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-10-30 to 1980-11-13
- 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 OECD Guideline 402.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- solvent-dewaxed light paraffinic, sufficiently refined, IP 346 <3% (CAS # 64742-56-9)
- IUPAC Name:
- solvent-dewaxed light paraffinic, sufficiently refined, IP 346 <3% (CAS # 64742-56-9)
- Details on test material:
- - Name of test material (as cited in study report): API 78-9 Solvent dewaxed light paraffinic oil
- CAS number: 64742-56-9
- Molecular weight (if other than submission substance): 322
- Substance type: Other Lubricant base oil (Sufficiently refined, IP 346 <3%)
- Physical state: Liquid
- Analytical purity: Not reported
- Composition of test material, percentage of components: Saturates - 88.7%; Aromatics - 11.3%
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
- Other:
Specific gravity 60/60: 0.8490
Viscosity: 64.2 SUS @ 100°F
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elkhorn Rabbitry (Watsonville, California)
- Age at study initiation: Not reported
- Weight at study initiation: 2.4 - 3.2 Kg
- Fasting period before study: Not reported
- Housing: Individual cage
- Diet (e.g. ad libitum): Purina Rabbit Chow® ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: From: 1980-10-16 To: 1980-11-13
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: stomach
- % coverage: 30%
- Type of wrap if used: Plastic wrap taped with porous adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With guaze sponges
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg (5 g/kg)
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg (5 g/kg)
- No. of animals per sex per dose:
- 4/sex/dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavioral - Day 0, and 2/day till Day 14; Mortality and local reactions - 2/day till Day 14; Body weight - Day 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed in male or female rabbits dosed with API 78-9 at 5000 mg/kg.
- Clinical signs:
- other: No visible signs of clinical toxicity were observed in male and female rabbits dosed with API 78-9 at 5000 mg/kg
- Gross pathology:
- No lesions attributable to test material administration were observed throughout the study period and 14-day post exposure observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dermal administration of API 78-9 at 5000 mg/kg did not result in any dermal irritation or signs of clinical toxicity. Gross necroscopy did not reveal any signs of systemic toxicity at the 5000 mg/kg dose level.
The acute dermal LD50 for API 78-9 is >5000 mg/kg. - Executive summary:
In an acute dermal toxicity study, API 78-9 was administered to 4 New Zealand White rabbits/sex at a dose of 5000 mg/kg for 24 hours. Prior to application of the test material the exposure sites of four rabbits were abraded by making epidermal incisions. The remaining four rabbits were left unbraded. Another group of eight (4/sex) rabbits were used as control animals.
Behavioral reactions were monitored through the 24 -hour contact period. Mortality, clinical signs of toxicity, and behavioral abnormalities were observed for twice daily through the 14 -daypost exposure observation period. Body weight was recorded for all animals on Day 0, 7, and 14 of the study period. On Day 14 all animals were necropsied and observed for gross pathological changes.
Dermal administration of API 78-9 at 5000 mg/kg did not result in any dermal irritation or signs of clinical toxicity. Gross necroscopy did not reveal any signs of systemic toxicity at the 5000 mg/kg dose level.
The acute dermal LD50 for API 78-9 is >5000 mg/kg
This study is classified as reliable without restriction because it was conducted according to OECD guideline 402.
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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