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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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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:
- repeated dose toxicity: oral
- Remarks:
- other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The data from the migrated NONS file is deficient, and the study has not been seen to confirm reliability. No guideline or GLP data has been provided, so the study could be highly unreliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Principles of method if other than guideline:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- GLP compliance:
- not specified
- Remarks:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- 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:
- C12H23NO
- IUPAC Name:
- N-(n-octyl)-2-pyrrolidinone
- Details on test material:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration: oral gavage (intragastric intubation)
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 55 mg/kg bw/day
Male: 5 animals at 320 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 5 mg/kg bw/day
Female: 5 animals at 55 mg/kg bw/day
Female: 5 animals at 320 mg/kg bw/day - Details on study design:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Positive control:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Examinations
- Observations and examinations performed and frequency:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Sacrifice and pathology:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Other examinations:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
- Statistics:
- Not given in information from migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No mortalities. 5 mg/kg bw/day: females showed increased salivation. 55 mg/kg bw/day: increased salivation and a hunched posture was observed. 320 mg/kg bw/day: increased salivation, hunched posture, abnormal gait (waddling), lethargy were observed.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No mortalities. 5 mg/kg bw/day: females showed increased salivation. 55 mg/kg bw/day: increased salivation and a hunched posture was observed. 320 mg/kg bw/day: increased salivation, hunched posture, abnormal gait (waddling), lethargy were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower for females in the high dosage group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower PCV and RBC counts, higher MCHC for males at 320 mg/kg bw/day. Higher neutrophil counts for females at 55 mg/kg bw/day, males and females at 320 mg/kg bw/day.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- GPT higher in females at 320 mg/kg bw/day. Lower albumin levels (and A/G ratios) for males at 55 and 320 mg/kg bw/day. Lower Ca levels for males at 320 mg/kg bw/day. Lower Cl levels for males at all levels.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Similar to those of the controls.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No macroscopic changes related to treatment.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- No histopathological changes related to treatment.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- No further details provided in the migrated NONS file as per inquiry # [06-0000024772-67-0000], permission to refer granted by ECHA
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 55 mg/kg bw/day (nominal)
- Based on:
- other: Original NCD unit is mg/kg/day
- Sex:
- not specified
- Dose descriptor:
- NOEL
- Effect level:
- ca. 55 mg/kg bw/day (nominal)
- Based on:
- other: original NCD unit is mg/kg/day
- Sex:
- not specified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- N-(n-octyl)-2-pyrrolidinone is not classified.
- Executive summary:
The migrated NONS file does not provide details on the guideline followed, or whether the study is GLP. The NOEL and NOAEL are both found to be 55 mg/kg bw/day. This is not at a level which provides a classification.
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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