Castor oil, dehydrated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Feb. 15, 1988 to Mar. 03, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although the study was conducted according to OECD Guideline 401 and EC Regulation 84/449/EWG

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EG-guidelines 84/449/EWG

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides C16-C18 and C18-unsatd.

IUPAC Name:

Glycerides C16-C18 and C18-unsatd.

Constituent 2

Reference substance name:

Glycerides, C16-18 and C18-unsatd.

EC Number:

266-948-4

EC Name:

Glycerides, C16-18 and C18-unsatd.

Cas Number:

67701-30-8

IUPAC Name:

67701-30-8

Details on test material:

- Name of test material (as cited in study report): Alkali-refined linseed oil (CAS N° 8001-26-1, EC N° 232-278-6). Under the SDA nomenclature, the substance name is 'Glycerides C16-C18 and C18 unsatd.'
- Substance type: Triglycerides of vegetable origin
- 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 Sulzfeld
- Weight at study initiation: male: 191.2 - 197.5 g and female: 170.8 - 185.6 g
- Fasting before study: Yes
- Housing: Collective caging, cage type: Macrolon type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 50 - 80%
- Photoperiod: Fluorescent light, 120 lux, 12 h/d from 7 a.m. to 7 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

4763 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Recorded at Day 0, 7 and Day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, organ weights, histopathology, other: CNS symptoms, coordination, tone, reflex, autonomic functions

Statistics:

None

Results and discussion

Preliminary study:

Two female rats were employed in a preliminary range finding study. The dose of the single oral administration was 5 mL/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 763 mg/kg bw

Remarks on result:

other: None

Mortality:

No mortalities were observed

Clinical signs:

other: No clinical signs were observed

Gross pathology:

No macroscopic findings in the cranial, thoracic and abdominal cavity

Other findings:

None

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 oral LD50 of linseed oil in rats was > 4,763 mg/kg bw.

Executive summary:

The acute oral toxicity of linseed oil was investigated in rats in accordance with OECD Guideline 401 and EG 84/449/EWG.

A single dose of 4,763 mg/kg bw of linseed oil was administered to 5 male and 5 female rats. Clinical signs, body weights and mortalities were recorded during the 14 d observation period. Immediately after death or at the end of the observation period, a complete necropsy was performed.

No mortality or any other adverse effect was observed in any of the animals.

The oral LD50 of linseed oil in rats was > 4,763 mg/kg bw.