Phosphatidylcholines, soya, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Principles of method if other than guideline:

Acclimatization time at least 7 days
No food for 16 hours before oral administration
1 administration of the test substance by oral gavage
4 hours post application food is made available
Observation for 14 days
Clinical observations and necropsy after the 14 day period

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphatidylcholines, soya, hydrogenated

EC Number:

306-549-5

EC Name:

Phosphatidylcholines, soya, hydrogenated

Cas Number:

97281-48-6

Molecular formula:

C44H88NO8P

IUPAC Name:

[(2R)-2,3-di(octadecanoyloxy)propyl] 2-(trimethylazaniumyl)ethyl phosphate

Test material form:

solid

Specific details on test material used for the study:

Test compound: PPC-H (P 0062/2/02)
Batch number 10339/2
White granules

Test animals

Species:

mouse

Strain:

NMRI

Remarks:

substrain: SPF (Han.)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Strain: NMRI mice
- Colour: white
- Weight at study initiation: male: male: 28.8-38.4 g; female: 22.1-24.0 g
- Fasting period before study: 16 h
- Housing: Macrolon type III/max 5 mice per cage
- Diet: ad libitum 4 hours after administration
- Water: ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50-85 %
- Photoperiod (hrs dark / hrs light): 12 hrs light (7 am - 7 pm)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Animals were dosed once orally by stomac tubes

Doses:

Single dose
Range finding study:
Group 1: 6.5 g/kg
Group 2: 10.3 g/kg
Final study
Group 1: 10 g/kg

No. of animals per sex per dose:

5 males / 5 females

Control animals:

not specified

Statistics:

NA

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 other: g/kg bw.

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 other: g/kg bw.

Based on:

test mat.

Mortality:

No mortality was observed after 24h and 14 days

Clinical signs:

other: no clinical toxicological symptoms

Gross pathology:

no macroscopic findings (cranial-, thoracic- and abdominal cavity) after 14 days

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality, weight changes, clinical signs nor macroscopic findings were observed in male and female mice exposed to the test item at 10 g/kg. LD50 was therefore > 10 g/kg for both males and females

Executive summary:

The acute oral toxicity of PPC-H was investigated in one group of fasted male and female NMRI mice. The mice were exposed to a single oral dose of the test item (10 g/kg) and observed for 14 days post exposure.

No mortality, weight changes, clinical signs nor macroscopic findings were in male and female mice exposed to the test item (10 g/kg).

LD50 is therefore reported as > 10 g/kg for both males and females