Castor oil, ethoxylated

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Repeated dose oral toxicity study for test chemical

Author:

Susan N. J. Pang

Year:

1997

Bibliographic source:

Cosmetic Ingredient Review; International Journal of Toxicology

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

The subchronic study was conducted to evaluate the toxic effects of repeated administration of test chemical to Sherman -Wistar rats by the oral(feed) route.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Castor oil, ethoxylated

EC Number:

500-151-7

EC Name:

Castor oil, ethoxylated

Cas Number:

61791-12-6

Molecular formula:

C57H104O9(CH2CH2O)n

IUPAC Name:

Castor oil, ethoxylated

Details on test material:

- Name of test material (as cited in study report): Castor oil, ethoxylated (PEG 40 Castor oil)
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

rat

Strain:

other: Sherman -Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:No data available
- Age at study initiation:No data available
- Weight at study initiation:No data available
- Housing:No data available
- Diet (e.g. ad libitum):No data available
- Water (e.g. ad libitum):No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C):No data available
- Humidity (%):No data available
- Air changes (per hr):No data available
- Photoperiod (hrs dark / hrs light):No data available

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: Diet

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency):Daily
- Mixing appropriate amounts with (Type of food):No data available
- Storage temperature of food:No data available

VEHICLE
- Justification for use and choice of vehicle (if other than water):Diet
- Concentration in vehicle:0.01%, 0.04%, 0.16%, 0.64%, 2.5%, and 5.0% (initially 10.0%) PEG- 40 Castor Oil.
- Amount of vehicle (if gavage):No data available
- Lot/batch no. (if required):No data available
- Purity:No data available

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

90 days

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0.01%, 0.04%, 0.16%, 0.64%, 2.5%, or 5.0% (initially 10 .0%) PEG- 40 Castor Oil .
Basis:

No. of animals per sex per dose:

0% (control) - 30 rats
0.01%, 0.04%, 0.16%, 0.64%, 2.5%, or 5.0% (initially 10 .0%) - 15 rats

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

BODY WEIGHT: Yes

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):Yes

HAEMATOLOGY: Yes
- Time schedule for collection of blood: Prior to the study and then periodically during th e study.
- How many animals: Two male and two female rats

Sacrifice and pathology:

GROSS PATHOLOGY: Yes ,
After 8 wk on the diet , the lightest two male and two female rats were killed for necropsy and tissues were removed for microscopic examination . At the end of the study, the lightest two male and two female rats also were killed for necropsy.

HISTOPATHOLOGY: Yes

Statistics:

No data available

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not specified

Effect levels

Dose descriptor:

NOAEL

Effect level:

5 000 mg/kg diet

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No effects observed on the following parameters examined : Body Weight Feed Intake Hematology Gross pathology Histopathology

Remarks on result:

other: No toxic effects were observed

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The oral administration of test chemical to rats at a dose level of 5000 mg/kg diet (5.0%). No effect observed on body weight ,feed intake, hematology as well as gross and histopathology. Thus the no observed adverse effect level (NOAEL) for repeated dose oral toxicity study was considered to be 5000 mg/kg diet (5.0%).

Executive summary:

The subchronic study was conducted to evaluate the toxic effects of repeated administration of test chemical.In a 90 - day feeding study, groups of 15 Sherman -Wistar rats were fed diets containing 0.01%, 0.04%, 0.16%, 0.64%, 2.5%, and 5.0% (initially 10 .0%) PEG- 40 Castor Oil . Weight gain , feed intake and hematology results were comparable between the experimental groups and the control group. No significant gross or microscopic lesions were found at either 8 wk or 90 days . Therefore no observed adverse effect level (NOAEL) of repeated dose study was considered to be 5000 mg/kg diet (5.0%).