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EC number: 300-226-2 | CAS number: 93924-32-4 A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985-12-17 to 1987-08-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was performed in compliance with OECD 414.
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 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Insufficient number of dams per group
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Solvent refined base oil, sufficiently refined, IP 346 < 3%
- IUPAC Name:
- Solvent refined base oil, sufficiently refined, IP 346 < 3%
- Details on test material:
- Read Across to Other Lubricant Base Oils
- Name of test material (as cited in study report): 100 SUS solvent refined base oil
- Substance type: Other lubricant base oil (IP 346 <3%)
- Lot/batch No.: CRU #84120
- Radiochemical purity (if radiolabelling): [1-14C]Octacosane
- Specific activity (if radiolabelling): 6.15 mCi/mmol
- Density = 0.86 g/mL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Kingston, NY)
- Age at study initiation: 10 and 8 weeks old
- Fasting period before study: No
- Housing: Dams were individually housed after mating.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: December 17, 1985 to January 2, 1986
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 40 to 60%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: Intact dorsal surface
- Type of wrap if used: No wrap was used
- Time intervals for shavings or clippings: Animals were clipped on gestation day 0 and once weekly thereafter
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing was performed
- Time after start of exposure: Test material was not removed after exposure.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 cc of 125, 500, or 2000 mg/kg/day
USE OF RESTRAINERS FOR PREVENTING INGESTION: Yes, Elizabethan-style collars - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data reported.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: Cohabitation period lasted until 55 presumed pregnant rats were obtained.
- Verification of same strain and source of both sexes: No
- Proof of pregnancy: Females were examined every morning during mating for vaginal sperm plugs. The drop-pans under the animals cages also were checked for expelled vaginal plugs daily. Vaginal lavage fluid was examined for the presence of spermatozoa in those dams that exhibited a vaginal plug either in situ or in the drop-pan. Females with the presence of spermatozoa and a vaginal plug were considered to be at day 0 gestation and placed in individual housing units. - Duration of treatment / exposure:
- The test material was applied on dose groups 2 through 4 on gestation days 0 through 19; a fifth dose group was used, in which dams were applied the base oil on gestation day 0-17. A base oil fortified with [1-14C]octacosane was administered on gestation day 18.
- Frequency of treatment:
- Daily
- Duration of test:
- The acclimation period started on 17 December, 1985. Visceral evaluations ended on August 27, 1987.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 125, 500, and 2000 mg/kg/day
Basis:
other: dermal exposure
- No. of animals per sex per dose:
- Control group (0 mg/kg/day): 15 animals
Group 2 (125 mg/kg/day): 10 animals
Group 3 (500 mg/kg/day): 10 animals
Group 4 (2000 mg/kg/day): 15 animals
Group 5 (2000 mg/kg/day plus [1-14C]octacosene: 5 animals - Control animals:
- yes, sham-exposed
- Details on study design:
- Groups 2 through 4 were administered 125, 500, 2000 mg/kg/day using a 1 cc syringe (calibrated in 0.01 cc). Dams were clipped on the dorsal surface, and the test material was dispensed evenly over the test site. Animals were fitted with Elizabethan-style collars. The control group was clipped and collared in a similar fashion. The dorsal skin of each rat was stroked with the tip of a 1 cc syringe, but no test material was applied. A fifth dose group was used, in which dams were applied the base oil on gestation day 0-17 at a dose level of 2000 mg/kg/day. A base oil fortified with [1-14C]octacosane was administered on gestation day 18.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least once daily
- Cage side observations included pathosis, abortion, premature delivery, and/or death.
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Gestation days 0, 3, 6, 10, 13, 16, and 20
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes; gestation days 0-3, 3-6, 6-10, 10-13, 13-16, and 16-20
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Thoracic and abdominal cavities of animals in groups 1 through 4 were exposed and all organs were grossly examined.
OTHER: Clinical chemistry endpoints were also evaluated. Blood samples were collected at the time of sacrifice from the aorta of each rat. Clinical chemistry endpoints measured are presented in Table 1 below.
Dose group 5 was sacrificed by over-exposure to ether on gestation day 20. Blood placentae, and foetuses were collected. Placental and foetal samples were homogenized prior to combustion, while blood samples were combusted directly. 14C Radioactivity was determined in combusted samples via a liquid scintillation counter. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: Live and dead foetuses - Fetal examinations:
- - External examinations (anomalies, malformations, and variations): Yes: all per litter
- Soft tissue examinations (anomalies, malformations, and variations): Yes: half per litter
- Skeletal examinations (anomalies, malformations, and variations): Yes: half per litter
- Head examinations: No data - Statistics:
- An ANOVA followed by Fisher's Exact or Dunnett's test was used to evaluated maternal biophase and caesarean section data. Foetal skeletal and visceral data were evaluated using Fisher's Exact test. Residue data was evaluated through a Student's t-test. Clinical chemistry data was evaluated using the F-test, which was employed to do an ANOVA on the serum data. The Student-Newman-Keul's multiple comparison test was then used. Differences between the control and treated animals were considered statistically significant if the probability of the differences being due to chance was less than 5%.
- Indices:
- Female mortality; viable female foetuses; viable male foetuses; and preimplantation loss
- Historical control data:
- No data reported.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Dermal application of the lubricant base oil to pregnant rats during gestation produced slight dermal irritation at all dose levels. At these dosages, the lubricant base oil produced erythema and flaking of the skin at the site of application in a dose-dependent manner. One animal in the 500 mg/kg/day dose group had dermal oedema. However, no other signs of test material-related toxicity were observed.
Effect levels (maternal animals)
- Dose descriptor:
- LOAEL
- Effect level:
- 125 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There was no evidence of teratogenicity. There were no treatment-related changes observed during external, skeletal, or visceral evaluations.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 000 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Skin Irritation (number affected/number examined) |
||||
Observation |
Dose Groups (mg/kg/day) |
|||
|
0 |
125 |
500 |
2000 |
Erythema |
0/15 |
1/10 |
4/10 |
9/15 |
Flaking of Skin |
0/15 |
2/10 |
2/10 |
4/15 |
Oedma |
0/15 |
0/15 |
1/15 |
0/15 |
Applicant's summary and conclusion
- Conclusions:
- Dermal administration of the base oil did not adversely affect maternal reproductive performance, nor did it affect offspring survival or development.
- Executive summary:
Read across justification
The physical and chemical properties of foots oils are comparable to the other lubricant base oil intermediate streams from which they are derived. Hence their health effects are also similar to those of other lubricant base oils, and the conclusions of the hazard assessment for other lubricant base oils also apply to foots oils.
In a developmental toxicity study, 100 SUS solvent refined base oil was administered to female Sprague Dawley rats dermally. There were five dose group. Groups 2 through 4 (10 dams/group in Groups 2 and 3; 15 dams/group in Group 4) were administered 125, 500, 2000 mg/kg/day using a 1 cc syringe (calibrated in 0.01 cc). Dams were clipped on the dorsal surface, and the test material was dispensed evenly over the test site. Animals were fitted with Elizabethan-style collars. The control group (Group 1; 15 dams/group) was clipped and collared in a similar fashion. For the control group, the dorsal skin of each rat was stroked with the tip of a 1 cc syringe, but no test material was applied. A fifth dose group (5 dams/group) was used, in which dams were applied the base oil on gestation day 0-17 at a dose level of 2000 mg/kg/day. A base oil fortified with [1-14C]octacosane was administered on gestation day 18.
Dermal application of the lubricant base oil to pregnant rats during gestation produced slight dermal irritation at all dose levels. At these dosages, the lubricant base oil produced erythema and flaking of the skin at the site of application in a dose-dependent manner. One animal in the 500 mg/kg/day dose group had dermal oedema. There were no other signs of maternal toxicity. Serum components were not adversely affected by the test material. According to the Group 5 results, the test material metabolites were able to pass across the placenta, but did not bioacculmulate in the foetuses. A maternal LOAEL was reported to be 125 mg/kg/day based on skin irritation.
There was no evidence of teratogenicity. There were no treatment-related changes observed during the external, skeletal, or visceral evaluations. Mean foetal weight and crown-rump lengths were comparable across all dose groups. A developmental/teratogenic NOAEL was reported to be ≥2000 mg/kg/day.
This study received a Klimisch score of 1 and is classified as reliable without restriction because this study is compliant with OECD Guideline 414.
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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