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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
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:
1984
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

Constituent 1
Reference substance name:
castor oil sulphated sodium salt
IUPAC Name:
castor oil sulphated sodium salt
Constituent 2
Chemical structure
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, sulphated, sodium salt
Test material form:
other: liquid
Details on test material:
- Name of test material: Castor oil sulfated sodium salt
- Molecular formula : no data
- Molecular weight: no data
- Smiles notation : no data
- InChl: no data
- Physical state: liquid
- Analytical purity: no data
- Storage condition of test material:no data

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:
DOSAGE PREPARATION : 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 motality observed
Clinical signs:
no data
Body weight:
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 test item castol oil is considered as non toxic substance.
Executive summary:

Castor oil sulphated sodium salt is administered by gavage on 10 wistar rats by method 67/548/ECC. Based on result (LD50>15600 mg/kg bw) the test item castol oil is considered as non toxic substance.