Registration Dossier
Registration Dossier
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EC number: 235-920-3 | CAS number: 13047-13-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 February 1985 to 09 April 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- test according to OECD 401 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- EC Number:
- 235-920-3
- EC Name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- Cas Number:
- 13047-13-7
- Molecular formula:
- C11H14N2O2
- IUPAC Name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for Breeding of Laboratory Animals TNO (CPB), Zeist, The Netherlands
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: males 176-250 g; females 123-156 g
- Fasting period before study: yes (overnight until 2-4.5 hours after dosing)
- Housing: individually in macrolon cages
- Diet: standard pelleted lab feed (RMH, Hope Farms) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 50-65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE: propylene glycol
MAXIMUM DOSE VOLUME APPLIED: not indicated
DOSAGE PREPARATION (if unusual): sonicated for 3 hours (suspension)
Rationale for the selection of the doses: pre-test in 1 male/1 female per group at 13, 18, 24 and 32 mg/kg bw --> no deaths
additional pre-test in 1 male/1 female per group at 1300, 2400 and 3200 (male only) --> all dead within 4 days. - Doses:
- 1100, 1500 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: once daily for mortality and clinical signs
- Frequency of weighing: on day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- LD50 value according to Finney (1971)
Results and discussion
- Preliminary study:
- pre-test in 1 male/1 female per group at 13, 18, 24 and 32 mg/kg bw --> no deaths
additional pre-test in 1 male/1 female per group at 1300, 2400 and 3200 (male only) --> all dead within 4 days.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 400 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 200 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1100 mg/kg bw: 2 males and 2 females (before day 6)
1500 mg/kg bw: 2 males and 4 females (before day 6)
2000 mg/kg bw: 4 males and 5 females (before day 6) - Clinical signs:
- other: apathy and lethargy during the initial days
- Gross pathology:
- in animals that died: diminution of antrum (sometimes with enlarged forestoach and petechiae in 5 animals; no abnormalities in others
in survivors: yellow granules in the stomach (2 animals); whitish material in the bladder (3 animals); no abnormalities in others
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 is 1300 mg/kg bw
- Executive summary:
Five rats per sex received a single dose of 1100, 1500 or 2000 mg/kg bw by gavage. During the 14 day observation period 4, 6 and 9 animals died at 1100, 1500 and 2000 mg/kg respectively. These animals showed decreased body weight, apathy and letargy and effects on the antrum. Other animals survived and showed no clear treatment related effects.
Based on these findings it is concluded that the LD50 is 1300 mg/kg bw (males and females combined).
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