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EC number: 292-660-3 | CAS number: 90669-78-6 A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
- 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

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985-01-14 to 1985-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because the study was conducted according to or similar to guideline study OECD TG 410.
- Justification for type of information:
- Concawe believes that dermal is the most relevant exposure route, and is sufficiently robust, to identify any potential hazards from repeated exposures to petroleum products to be able to adequately manage the potentially associated risks. However, the primary objective of the testing required for REACH is the identification of hazard, for which the default exposure route under the regulation is oral as this is considered to maximise systemic exposure. To address the regulatory exposure route issue, Concawe will review the current data base for evidence of systemic toxicity after dermal exposure and will also conduct a number of oral OECD 422 studies on prioritized substances in each relevant petroleum category. The document attached provides a concise overview of the information to further support the dermal route of exposure and proposed additional work, as part of a larger testing strategy (the strategy document can be found in Annex 13).
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 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 64741-50-0
- Cas Number:
- 64741-50-0
- IUPAC Name:
- 64741-50-0
- Reference substance name:
- Unrefined light paraffinic distillate
- IUPAC Name:
- Unrefined light paraffinic distillate
- Test material form:
- other: oily liquid
- Details on test material:
- - Name of test material (as cited in study report): Light Paraffinic Distillate
- Test substance: Unrefined light paraffinic distillate
- Molecular weight (if other than submission substance): 296
- Physical state: Liquid (light amber)
- CAS number: 64741-50-0
- Viscosity, cSt: 2.67 at 100°C
- API Gravity: 31.5
- Flash Point: (°F) 372
- Sulfur, Wt %: 0.2
- Nitrogen ppm: 256
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- Composition of test material, Wt. %:
Olefins: 39.7
Naphthenes 21.7
- PONA % by MS: 37
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: Only specified as young adult
- Weight at study initiation: Males:2.1 kilograms to 3.3 kilograms; females: 2.3 kilograms to 3.2 kilograms
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26
- Humidity (%): 18 to 40%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From: 1985-01-14 To:1985-02-15
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: Dorsal trunk area
- % coverage: 10%
- Type of wrap if used: Gauze followed by a sheet of polyurethane
- Time intervals for shavings or clippings: 24 hours before first application and as needed throughout the study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently wiped with a dry, clean, absorbent gauze pad
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Amount varied depending on weight
- Constant volume or concentration used: No
USE OF RESTRAINERS FOR PREVENTING INGESTION: No - Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 6 hours each day
- Frequency of treatment:
- 3 times each week for a total of 12 applications
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 1000 and 2000 mg/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- Five animals per sex per dose; however, one of the animals in the 1000 mg/kg group was mis-sexed so there were 4 males and 6 females in this group.
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: A preliminary dose-range study was conducted
- Rationale for animal assignment (if not random): Not reported - Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
- Cage side observations checked included mortality, morbidity, and overt signs of toxicity.
DETAILED CLINICAL OBSERVATIONS: No data
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: At study initiation and weekly throughout the study period
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At study termination
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: All animals
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At study termination
- Animals fasted: No data
- How many animals: All animals
- Parameters checked in table 2 were examined.
URINALYSIS: No, but samples were collected from the control and high-dose group for possible evaluation
- Time schedule for collection of urine: At study termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, specified as a complete necropsy
HISTOPATHOLOGY: Yes (see table 3) - Other examinations:
- Heart, liver, kidneys, adrenals, thyroid with parathyroid, pituitary, testes, ovaries and brain were weighed.
- Statistics:
- Two-tailed Student's t-test with p<0.05
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There were no treatment-related effects of clinical signs or mortality.
BODY WEIGHT AND WEIGHT GAIN: High-dose males and females had lower body weight and body weight gains compared to the control.
HAEMATOLOGY: There were no treatment-related effects on haematology.
CLINICAL CHEMISTRY: There were no treatment-related effects on clinical chemistry.
ORGAN WEIGHTS: Although there were several significant changes in the organ weights of high-dose animals, the changes are secondary to the reduced body weight in this group and not directly related to treatment.
GROSS PATHOLOGY: The only gross findings related to treatment were changes in the treated skin and included dry, scaly, rough, and/or reddened skin and thickened epidermis in all treatment groups.
HISTOPATHOLOGY: NON-NEOPLASTIC: Slight to moderate proliferative changes of the skin occurred in all high-dose animals.
HISTOPATHOLOGY: NEOPLASTIC: There were no noted neoplastic changes.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: body weight
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: dermal irritation
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 12.5 mg/cm² per day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Mild dermal irritation
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Three animals died during the study but these were not dose-related and were, therefore, considered unrelated to treatment. Sporadic clinical signs were also unrelated to treatment. In the high dose group, body weight gains were affected by treatment. In the females, there was a group net loss in weight whereas in the males the gains were significantly less than controls. These effects were largely due to effects on growth rate during the first week of the study. A mean irritation index was calculated for each group each day and also for each treatment group overall. The value was determined from Draize scores for erythema and oedema for each animal. The mean irritation scores for each group were:
Group |
Irritation score |
Control (male) |
0 |
Control (female) |
0 |
200 mg/kg (male) |
0.5 |
200 mg/kg (female) |
0.4 |
1000 mg/kg (male) |
1.7 |
1000 mg/kg (female) |
2.0 |
2000 mg/kg (male) |
3.1 |
2000 mg/kg (female) |
3.2 |
There
were no statistical differences between treated and control groups for
any of the haematological determinations. The
clinical chemical data for the treated and control males was similar. In
the females, there was a reduced BUN and an increased SGPT for the
low-dose females. Since
no other differences were noted and that values were within normal
limits the effects were not considered to be toxicologically significant. The
following absolute and relative organ weight differences (compared to
controls) were recorded.
Males |
Females |
|
2000 mg/kg |
||
Relative liver wt. |
Increased |
Increased |
Relative kidney wt. |
Increased |
Increased |
Relative pituitary wt |
Increased |
|
Relative left testis |
Decreased |
|
Relative brain wt |
Increased |
|
1000 mg/kg |
||
Abs. Rt. kidney wt |
Decreased |
|
Abs. Heart wt |
Decreased |
None
of the organ weight differences were considered treatment-related. The
higher than control relative organ weights were considered as a function
of the reduced body weights in the affected animals.
The only findings at gross necropsy were confined to the treated skin. These
consisted of dry, scaly, rough, and/or reddened skin and thickened
dermis. These findings were noted throughout the treatment groups. There
were no treatment-related gross necropsy findings in the internal organs.
Microscopic pathology findings were also largely confined to the skin. Slight
to moderate proliferative changes of the skin were present in all of the
male and female rabbits in the highest dose group.
The testes of one of the five males in the high dose group had bilateral
diffuse tubular hypoplasia accompanied by aspermatogenesis and
hypoplasia of the epididymis. These
changes were considered to represent immature testes. Similar
changes were not seen in the other animals in this dose group.
Applicant's summary and conclusion
- Conclusions:
- The systemic LOAEL for this study is 2000 mg/kg/day, based on the reduced body weights and the systemic NOAEL in this study is 1000 mg/kg/day. The dermal LOAEL is 200 mg/kg/day and the dermal NOAEL is <200 mg/kg/day, based on the irritation at the treatment site.
- Executive summary:
Read across justification
No dermal repeat dose toxicity studies have been reported for slack waxes (carcinogenic or unknown feed-stock), but a study has been reported for unrefined / acid treated lubricant base oils, materials similar to the oil entrained in slack waxes (carcinogenic or unknown feed-stock).
A 28-day dermal repeated-dose study was conducted in New Zealand white rabbits with API 84-01, an unrefined light paraffinic distillate (CAS No. 64741-50-0). In this study, the undiluted test material was applied at doses of 200, 1000 and 2000 mg/kg, once a day, three times a week for 4 weeks to the shorn dorsal skin of groups of five male and five female rabbits. The applied material was covered with an occlusive dressing for 6 hours and was then removed. At that time, the skin was wiped with dry gauze to remove any residual material. A group of five rabbits of each sex served as sham controls. The test skin site of each animal was examined and scored for irritation prior to each application of test material. Mortality and morbidity checks were performed twice daily, and body weights were recorded weekly. At termination, blood samples were taken for a range of haematological and clinical chemical measurements. Urine samples were also collected and frozen for possible future examination. A complete gross necropsy was performed on all animals. Major organs were weighed, and tissues were processed for subsequent histopathological examination.
Treatment-related findings included erythema and oedema in the 1000 and 2000 mg/kg groups with increasing frequency and severity with increasing dose,i.e.,the 2000 mg/kg group displayed moderate irritation and proliferative changes in the skin. Only minimal irritation was observed in the 200 mg/kg dose group. Bodyweight losses were observed in 1 male and 3 females at 2000 mg/kg, and the group mean bodyweights were significantly less than the controls. There was no other evidence of systemic toxicity. No treatment-related trends were evident based on the haematology, clinical chemistry or organ weight data. The deaths of a low dose female, a high dose male and a sham-treated control male were not considered to be treatment-related. The systemic NOAEL in this study was 1000 mg/kg/day. The dermal NOAEL was <200 mg/kg/day based on the irritation at the treatment site.
This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was conducted according to or similar to guideline study OECD TG 410.
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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