Fatty acids, rape-oil, Me esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1988-03-22 to 1988-04-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions

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:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, palm-oil, Me esters

EC Number:

293-086-6

EC Name:

Fatty acids, palm-oil, Me esters

Cas Number:

91051-34-2

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Fatty acids, palm-oil, methyl esters

Details on test material:

- Name of test material (as cited in study report): Palmölfettsäure-methylester
- Physical state: liquid, yellow
- Lot/batch No.: TK 333

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann GmbH, Germany
- Weight at study initiation: Mean weights: Male: 175 g, Female: 153 g
- Housing: Groups of 5 animals in Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet (e.g. ad libitum): ad libitum (Altromin Maintainance diet 1324)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (g/v)
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

5000 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 days
- Frequency of observations and weighing: Mortality/Toxicity: At frequent intervalls during test day one and twice daily on days 2 - 14; body weight on days -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes, Macroscopic examintion of organs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: rat

Mortality:

No deaths occurred (one dead female animal after 11 days was not related to treatment)

Clinical signs:

other: No symptoms observed

Gross pathology:

Male: No findings
Female: No findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU