Registration Dossier
Registration Dossier
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EC number: 403-700-8 | CAS number: 2687-94-7 NOP; SURFADONE LP-100 SURFACTANT
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
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:
- - Name of test material (as cited in study report): N-(N-Octyl)pyrrolidone; Substance No. 91/453
- Physical state: colorless liquid
- Analytical purity: 99.3 %
- Lot/batch No.: 103/90
- Storage condition of test material: refrigerator
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. Thomae GmbH, D-W7950 Biberach
- Age at study initiation: young adults
- Weight at study initiation: 150-300 g
- Fasting period before study: 16 hrs
- Housing: individual
- Diet: Kliba laboratory diet, Klingenthalermühle, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: solution in olive oil DAB 9
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 and 44 g/100 ml
- Amount of vehicle (if gavage): 5 ml/kg
- Justification for choice of vehicle: test substance is insoluble in water
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg - Doses:
- 1000, 2200 mg/kg
- No. of animals per sex per dose:
- 5 males and females per dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily on working days, recordings of signs and symptoms several times/day; once on weekends
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 mg/kg bw
- Mortality:
- no death occurred in any of the dosing groups
- Clinical signs:
- other: In male animals no clinical signs were noted in the 1000 mg/kg dosing group, female animals showed dyspnoea, apathy, abdominal position, staggering, piloerection exsiccosis and exophthalmos and poor general state in the first 4 hours after dosing. In the
- Gross pathology:
- no pathologic findings noted
Applicant's summary and conclusion
- Interpretation of results:
- not classified
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