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EC number: 265-232-9 | CAS number: 64771-71-7 A combination of normal paraffins having carbon numbers predominantly greater than C10 obtained by urea adduction or molecular sieve processes.
- 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

Neurotoxicity
Administrative data
- Endpoint:
- neurotoxicity
- Remarks:
- subacute
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1993/04/20-1993/04/27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 424 (Neurotoxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics
- IUPAC Name:
- Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics
- Details on test material:
- - Name of Test Material (in study): MRD-92-405
- Analytical purity: Assumed 100% pure
- Description: Colorless liquid
- Storage: Room Temperature
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: Hazelton Research Products
- Age at study initiation: Males: 13 weeks; Females: 11-12 weeks
- Weight at study initiation: Males: 1.96-2.19 g; Females: 1.90-2.26g
- Housing: Single Housed
- Diet (e.g. ad libitum): Agway Certified Diet RCA Rabbit, restricted feeding
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65 to 70
- Humidity (%): 40 to 60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- other: occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: dorsal surface
- % coverage: 10
- Type of wrap if used: appled under the gauze patch and secured with a piece of Saran wrap
- Time intervals for shavings or clipplings: twice per week
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed the dosed site with 1.0% mixture of baby shampoo
- Time after start of exposure: after 6 hours of exposure, the test material was washed off
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 6 hours a day; applied once a day for the duration of the experiment
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
doses: 500, 1000, 2000 mg/kg positive control (n-hexane): 2000 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 2 males and 2 females per treatment group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The study was conducted to assess the dermal irritation potential and systemic toxicity of repeated topical application of MRD-92-405 at dose levels of 500, 1000, and 2000 mg/kg in the rabbit when administered daily for 7 days. Four groups consisting of 2 rabbits/sex/group were used. To serve as a comparison control, one group of animals was treated with n-hexane.
Clinical observations were made daily as to the nature, onset, severity, and duration of toxicological signs. Dermal irritation was assessed prior to dosing on days 0, 4, and 7 and immediately after dosing on Day 0. Body weights were recorded the week prior to dosing, on day 0 and day 7. Food consumption was measured once during the test period. The study was terminated after 7 days of dosing and all rabbits in the 2000 mg/kg group and n-hexane group were subjected to whole body perfusion fixation. A modified gross necropsy, which did not include examination of the cranial cavity, was conducted on each of these animals. A gross necropsy was performed on the 500, 1000 mg/kg dosed animals and tissues with gross abnormalities were taken and preserved. Positive control (n-hexane): 2000 mg/kg
Examinations
- Observations and clinical examinations performed and frequency:
- Clinical observations were made daily as to the nature, onset, severity, and duration of toxicological signs. Dermal irritation was assessed prior to dosing on days 0, 4, and 7 and immediately after dosing on Day 0. Body weights were recorded the week prior to dosing, on day 0 and day 7. Food consumption was measured once during the test period.
- Sacrifice and (histo)pathology:
- The study was terminated after 7 days of dosing and all rabbits in the 2000 mg/kg group and n-hexane group were subjected to whole body perfusion fixation. A modified gross necropsy, which did not include examination of the cranial cavity, was conducted on each of these animals. A gross necropsy was performed on the 500, 1000 mg/kg dosed animals and tissues with gross abnormalities were taken and preserved.
- Statistics:
- Means and standard deviations of body weight, body weight change, and food consumption.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
All animals survived to the end of the study. All animals in the 1000 and 2000 mg/kg dose groups were observed with erythema, ranging from very slight to severe, throughout the study. The severity of erythema for these two groups increased as the study progressed. Two of the four 500 mg/kg dose group animals were observed with very slight to well-defined erythema on days 4 and 7. All animals in the n-hexane group were observed with erythema on days 4 and 7, ranging from very slight to severe. One n-hexane group animal was observed with very slight erythema on day 0. Edema, ranging from very slight to slight, was observed in all dose groups on days 4 and 7. Supplemental dermal observations consisting of desquamation and/or exfoliation, atonia, and cracking were observed in all dose groups on day 7. Fissuring was observed in the 1000 mg/kg and 2000 mg/kg groups and in the n-hexane group. One n-hexane dose group animal was observed with eschar on day 7. No additional observable abnormal clinical signs were noted in treated animals except for one female animal that was observed with mucoidal stool on day 2.
BODY WEIGHT AND WEIGHT GAIN
There were small decreases in body weight from the day 0 weights observed in individual animals from all groups.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
There were no apparent differences in food consumption between the groups.
GROSS PATHOLOGY
Dermal irritation was the most significant postmortem finding and was consistent with the supplemental dermal observations noted. No other finding was considered the result of test material administration.
NEUROTOXICITY
Topical application of MRD-92-405 for seven days did not cause any gross signs of neurotoxicity.
Effect levels
- Dose descriptor:
- NOAEC
- Remarks:
- LD50
- Effect level:
- >= 2 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no sub-acute neurotoxicity noted
- Remarks on result:
- other:
Applicant's summary and conclusion
- Conclusions:
- Dermal application of 2000mg/kg MRD-92-405 for seven days did not cause any gross signs of neurotoxicity or any clinical signs except for skin irritation. All animals survived to study termination; NOAEC >2000 mg/kg.
- Executive summary:
The study was conducted to assess the dermal irritation potential and systemic toxicity of repeated topical application of MRD-92-405 at dose levels of 500, 1000, and 2000 mg/kg in the rabbit when administered daily for 7 days. Four groups consisting of 2 rabbits/sex/group were used. To serve as a comparison control, one group of animals was treated with n-hexane. Dermal application of 2000mg/kg MRD-92-405 for seven days did not cause any gross signs of neurotoxicity or any clinical signs except for skin irritation, with erythema ranging from very slight to severe. All animals survived to study termination; NOAEC >2000 mg/kg.
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