Registration Dossier
Registration Dossier
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EC number: 473-370-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 February 2007 to 15 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF
- Version / remarks:
- 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 473-370-8
- EC Name:
- -
- Cas Number:
- 13304-62-6
- Molecular formula:
- C10 H11 N O
- IUPAC Name:
- N-benzylprop-2-enamide
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzbach, Germany
- Strain: Crl:WI (outbred, SPF quality)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 185-251 g
- Fasting period before study: overnight (max 20 h) until 3-4 hours post-dosing
- Housing: 3/cage (Macrolon MIV) saw dust bedding, paper as enrichment
- Diet: Pelleted Rodent Diet ad libitum (SM R/M-Z SSNIFF Soest Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1-23.3 ˚C
- Humidity (%): 40-65%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): <=10 mL/kg
- Justification for choice of vehicle: laboratory trial
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: prepared within 4 hours before dosing (homogeneity assessed visually) adjusted for specific gravity (1.036)
CLASS METHOD
- Rationale for the selection of the starting dose: not indicated - Doses:
- 2000 mg/kg bw (first trial), 300 mg/kg bw (second and third trial)
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Bodyweight: on day 1 (pre-dose), 8 and 15
- Necropsy of survivors performed: yes
- Mortalith: twice daily
- Clinical signs: several times on day 1, daily thereafter - Statistics:
- NA
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- at 2000 mg/kg bw: 2/3 females were found dead within 24 hours after dosing
at 300 mg/kg bw: no mortality - Clinical signs:
- other: at 2000 mg/kg bw: lethargy, hunched/flat posture, laboured respiration, rales, watery discharge from the eyes, piloerection at 300 mg/kg bw: hunched posture, piloerection, ptosis
- Gross pathology:
- decedents: beginning autolysis
survivors: no abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the substance is between 300 and 2000 mg/kg bw
- Executive summary:
In a study according to the acute toxic class method 3 females per group received a single dose at 2000 mg/kg bw and 300 mg/kg bw. At 2000 mg/kg bw 2/3 females were found dead within 24 hours. Necropsy showed beginning autolysis. Clinical signs at 2000 mg/kg bw included lethargy, hunched/flat posture, laboured respiration, rales, watery discharge from the eyes and piloerection. At 300 mg/kgbw (2 trials) all females survived. Clinical signs included hunched posture, piloerection an ptosis.
In surviving animals of both dose groups no effects on body weight were found and macroscopic evalution did not show any abnormaities.
The LD50 is between 300 and 2000 mg/kg bw.
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