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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
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- Nanomaterial pour density
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- 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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 26 October to 12 December 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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.: 20.9.88/2
Purity: not specified
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England
- Age at study initiation: approximately 35 days old
- Weight at study initiation: between 22 and 24 grams
- Assigned to test groups randomly: yes
- Fasting period before study: overnight
- Housing: kept in a plastic disposable cage
- Diet (e.g. ad libitum): pelleted Labsure LAD 1 rodent breeding diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: approximately 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%):
- Air changes (per hr): 30 changes of air per hour.
- Photoperiod (hrs dark / hrs light): The room was illuminated by artificial light for 12 hours per day.
IN-LIFE DATES: From: 26 October 1988 To: 12 December 1988
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn oil
- Duration of treatment / exposure:
- Immediately
- Frequency of treatment:
- Single dose
- Post exposure period:
- 24, 48 or 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1720 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- Preliminary toxicity test:
2 males and 2 females per dose for Phase I.
5 males and 5 females per dose for Phase II.
Micronucleus test:
15 males and 15 females for vehicle control.
20 males and 20 females for the test substance.
5 males and 5 females for positive control. - Control animals:
- yes
- Positive control(s):
- Mitomycin C
- Justification for choice of positive control(s):
- Route of administration: Oral by intragastric gavage.
- Doses / concentrations: 12 mg/kg
Examinations
- Details of tissue and slide preparation:
- The femurs were cleared of tissue and one epiphysis removed from each bone. A direct bone marrow smear was made onto a slide containing a drop of calf serum. One smear was made from each femur. The prepared smears were fixed in methanol. The smears were air-dried and stained for 10 minutes in 10% Giemsa. Following rinsing in distilled water and differentiation in buffered distilled water, the smears were air-dried and mounted with coverslips using DPX.
- Evaluation criteria:
- None stated
- Statistics:
- For a comparison of an individual treated group with a concurrent control group, Wilcoxon's sum of ranks test is used.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Signs and mortalities:
One male and three female animals died after treatment with the test substance in the main study. On post mortem examination, none of the animals showed signs of having been misdosed. None of the animals in the positive control or vehicle control groups showed any clinical signs for the duration of the test.
Micronucleated polychromatic erythrocyte counts (mnp):
The test substance did not cause any statistically significant increases in the number of micronucleated polychromatic erythrocytes at any of the three skill times (P>0.05 using Wilcoxon's sum of ranks test). Mitomycin C caused large, highly significant increases (P<0.001) in the frequence of micronucleated polychromatic erythrocytes.
Micronucleated normochromatic erythrocytes (mnn):
The test substance did not cause any substantial increases in the incidence of micronucleated normochromatic erythrocytes at any of the three kill times.
Ratio of polychromatic to normochromatic erythrocytes (p/n):
Both the test substance and mitomycin C failed to cause any significant decreases in the ratio of polychromatic to normochromatic erythrocytes (P>0.05 using Wilcoxon's sum of ranks test).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
From the results obtained it is concluded that the test substance shows no evidence of mutagenic potential or bone marrow cell toxicity when administered orally in this in vivo test procedure. - Executive summary:
In a GLP compliant Mammalian Erythrocyte Micronucleus test according to OECD guideline 474, mice were once orally dosed with 1720 mg/kg bw test substance in corn oil and bone marrow cells were examined 24, 48 and 72 h later (1989). In contrast to the positive control, no increase of micronucleated PCE was observed, but one male and 3 female animals died after test substance administration. No substantial increase of NCEs and no significant decrease of the PCE/NCE ration was observed after administration of the test substance or the positive control.
Therefore, the test substance showed no evidence of mutagenic potential or bone marrow cell toxicity under the conditions of this test.
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