Registration Dossier
Registration Dossier
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EC number: 269-124-2 | CAS number: 68187-77-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Good study, no GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 67/548/CEE
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Castor oil, sulfated, sodium salt
- EC Number:
- 269-123-7
- EC Name:
- Castor oil, sulfated, sodium salt
- Cas Number:
- 68187-76-8
- Molecular formula:
- Not applicable
- IUPAC Name:
- Castor Oil, sulfated, sodium salt
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nossan Correzzana
- Weight at study initiation: 200 g
- Fasting period before study:last night before starting experiment, and 4 hours after dose administration
- Housing: 5 per cage in transparent polycarbonate cage 1290
- Diet: commercial pellet, ad libitum.
- Water: municipal filtered tap water,, ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20±1
- Humidity (%):55±15
- Air changes (per hr):8
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- administered volume : 1.5 mg/100gr bw
- Doses:
- 15600 mg/kg
- No. of animals per sex per dose:
- 5 x sex x dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing:before treatment
- Necropsy of survivors performed: yes
- Other examinations performed: gastro-intestinal tract, Peripheral nervous system, central nervous system, urine analisys, cardiovascular, respiratory, - Statistics:
- LD50 was calculated by Thompson-Weil method.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 15 600 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 600 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on result (LD50>15600 mg/kg bw) the analogue substancel is considered as non toxic substance.
- Executive summary:
Analogue substance 1 is administered by gavage on 10 wistar rats by method 67/548/ECC. Under the experimental conditions the substance showed a LD50>15600 mg/kg
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