Castor oil, sulfated, sodium salt

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

castor oil sulphated sodium salt

IUPAC Name:

castor oil sulphated sodium salt

Constituent 2

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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 15 600 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 600 mg/kg bw

Based on:

test mat.

Mortality:

no motality 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 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.