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EC number: 403-700-8 | CAS number: 2687-94-7 NOP; SURFADONE LP-100 SURFACTANT
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27 Sep 1990 to 2 July 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-1 (90-Day Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-(n-octyl)-2-pyrrolidinone
- EC Number:
- 403-700-8
- EC Name:
- N-(n-octyl)-2-pyrrolidinone
- Cas Number:
- 2687-94-7
- Molecular formula:
- C12 H23 N O
- IUPAC Name:
- 1-octylpyrrolidin-2-one
- Details on test material:
- Batch No.: KC90731
Purity: 99.6%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, MI
- Age at study initiation:approximately 4 weeks
- Weight at study initiation: The weight range was 182-211 grams for the males and 127-160 grams for the females.
- Fasting period before study:
- Housing: in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow #5002 (ground meal)
- Water (e.g. ad libitum): ad libitum fresh water (municipal source)
- Acclimation period: 14days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-79°F
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): diets were prepared for seven- or fourteen-day feeding period
- Mixing appropriate amounts with (Type of food): 1% corn oil
- Storage temperature of food: at room temperature
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Lot/batch no. (if required):Lot no.s were in report. NOV2590A, MAY2891A, JUL1691A
- Purity: - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test diets were analyzed for verification of test article concentration after each preparation during the first month and monthly thereafter.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
60, 600, 6000ppm (increased to 8000 ppm and again to 10000 ppm)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- Dosage conversion ppm in diet to mg/kg bw/day:
60 ppm = 4-7 mg/kg (females) and 3-7 mg/kg (males)
600 ppm = 43-69 mg/kg (females) and 33-65 mg/kg (males)
10000ppm = 608-924 mg/kg (females) and 492-718 mg/kg (males)
The study consisted of a control and 3 treated groups with 10 animals per sex in each group. The test article was blended with rodent meal to prepare dietary concentrations of 60, 600 and 6000 ppm. Due to the lack of frank toxicity at the high-dose level, the concentration of the test was increased from 6000 to 8000 ppm on study day 29 and from 8000 to 10000 ppmon study day 43. Control animals were fed basal diet.
All animals were observed daily for clinical signs of toxicity. Body weights and food consumption were measured and recorded weekly. Clinical pathology and ophthalmology examinations were performed at or near the end of the treatment period. All tissues collected from control and high-dose animals, all tissues from animals sacrificed during the study and the lungs, liver, kidneys and gross lesions from all low- and mid-dose animals were processed for histopathological examination.
Examinations
- Observations and examinations performed and frequency:
- All animals were observed daily for clinical signs of toxicity. Body weights and food consumption were measured and recorded weekly. Clinical pathology and ophthalmology examinations were performed at or near the end of the treatment period.
- Sacrifice and pathology:
- At the end of the treatment period (study days 92 and 91), all surviving rats were sacrificed. Half of the rats from each dose-sex group were sacrificed each day.
GROSS PATHOLOGY:The animals were subjected to a complete necropsy examination which included examination of the external surfaces, the cranial, thoracic, abdominal and pelvic cavities and their viscera.
HISTOPATHOLOGY: All tissues collected from control and high-dose animals, all tissues from animals sacrificed during the study and high-dose animals, all tissues from animals sacrificed during the study and the lungs, liver, kidneys and gross lesions from all low- and mid-dose animals were processed for histopathological examination. - Other examinations:
- Organ weights
- Statistics:
- Statistical analyses were performed by a Digital VAX 11/730 computer. All tests were two-tailed with a minimum significance level of 5%. Continuous data including body weights, body weight gains, food consumption, organ weights, and clinical pathology data were analyzed by one-way analysis of variance(ANOVA). When significance was observed with ANOVA, group by group comparison was performed with Dunnett's Test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Dietary administration of the substance produced signs of systemic toxicity in both males and females at the 10000 ppm level. Reduced body weight gain and/or food consumption, increased absolute and relative liver weights and minimal to mild hepatocyte hypertrophy were observed in the 10000 ppm group. No treatment-related mortalities or clinical signs of toxicity were observed during the study and no treatment-related differences were noted in the clinical pathology, ophthalmology or gross necropsy observations for males or females in any of the study groups. No treatment-related changes were observed in body weight gain, food consumption, organ weights and histopathology for males or females in the 60 and 600 ppm groups.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 600 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 600 ppm = 43-69 mg/kg (females) and 33-65 mg/kg (males)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Dietary administration of the substance for at least 90 days produced signs of systemic toxicity in both males and females at the 10000 ppm level. Reduced body weight gain and/or food consumption, increased absolute and relative liver weights and minimal to mild hepatocyte hypertrophy were observed for both males and females in the 10000 ppm group. Therefore, based on the results of this study, a level of 600 ppm was considered a no-observed-effect level (NOEL) for systemic toxicity following dietary administration of the substance for at least 90 days.
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