Glycerides, C16-18 and C18-unsatd., deodorizer distillates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not available

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines in compliance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Remarks:

U.S. Fed. Reg., Titel 21, Dec. 22nd, 1978, part II

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy

IUPAC Name:

Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy

Details on test material:

Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'
- Physical state: Slight yellow, clear oil
- pH: 6.5
- Storage condition of test material: Normal room temperature, in darkness

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfe1d
- Weight at study initiation: Male: 176.4 - 188.9 g; Female: 151.4 - 158.1 g
- Fasting period before study: Yes, 16 h before administartion of the test material
- Housing: Collective caging in macrolon type III/max. 5
- Diet: Ssniff-R Alleindiat flilr Ratten feed, ad libitum
- Water (e.g. ad libitum): Macrolon drinking bottles, Becker & Co. 4620 Castrop-Rauxel, ad libitum
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature: 20±2 °C
- Humidity: 50-80%
- Air changes (per hr):
- Photoperiod: 12 h dark/12 h light


IN-LIFE DATES: From: Feb. 19, 1988 To: March 3, 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Undiluted


MAXIMUM DOSE VOLUME APPLIED: 0.95 mL (1 mL = 0.9904 g XM out of 10 weighings)

Doses:

5 mL/kg

No. of animals per sex per dose:

5 male/female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Clinical observations: About 20 min, 1-2 h, 3-6 h, 24/48 h, Days 3- 6 and 7-14; Body weight: At Days 0 (beginning of the experiment), 7 and 14; Necropsy: Immediately after death of animal and after sacrifice, at the end of the 14 d observation period all surviving
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, gross pathology, mortality

Statistics:

Not reported

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: = 4952 mg/kg

Mortality:

No mortalities were observed

Clinical signs:

other: No clinical-toxicological symptoms observed

Gross pathology:

No macroscopic findings in the cranial, thoracic and abdominal cavity

Other findings:

Not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test substance is considered to be greater than > 5 mL/kg = 4,952 mg/kg bw.

Executive summary:

In order to evaluate the acute oral toxicity of ‘glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy’ (as castor oil) in rats, an acute oral toxicity study was conducted. The procedure performed in this study was based on the OECD Guideline 401, 1987 and to GefStoffV, Aug. 26th, 1986, (BGBI 1470).

A group of 5 fasted male and female Wistar rats were exposed to a single oral dose of 5 mL/kg bw. Clinical signs and mortality were recorded during the 14 day observation period. Necropsy was conducted on moribund animals and those terminated at test end.

No clinical signs and no mortality were observed. There were no treatment-related effects on body weight and nothing abnormal was found in the animals necropsied on Day 14.

The acute oral median lethal dose (LD₅₀) of the test substance was therefore considered to be > 5 mL/kg = 4,952 mg/kg bw.