Phosphatidylcholines, soya, hydrogenated

Endpoint summary

Description of key information

The acute oral toxicity of Phosphatidylcholine hydrogenated was investigated in one group of fasted male and female NMRI mice and WISW rats. The mice and rats 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, no clinical signs nor macroscopic changes were found in NMRI mice or WISW rats exposed to the test item (10 g/kg). LD50 is therefore reported as > 10 g/kg.

The acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenated is assessed in a weight of evidence approach using available data on the group of lecithins. Dermal acute toxicity is assessed based on the low oral acute toxicity and a study with phosphatidylserine administrated subcutaneously reporting the LD50 value to be greater than 5 mg/kg bodyweight. All available studies on acute toxicity by other routes show a low acute toxicity of phosphatidylcholines, soya, hydrogenated and lecithins, with a LD50 of more than 4000 mg/kg bw. Although a relatively high dermal absorption of lecithins have been shown, the potential of acute dermal toxicity is evaluated to be low due to the high LD50 values reported.

The overall conclusion based on presented data in this weight of evidence analysis, is that there are no indications of acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenated.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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

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

Specific details on test material used for the study:

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

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)

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

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 other: g/kg bw.

Based on:

test mat.

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

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

Reference 2

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

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

Specific details on test material used for the study:

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

Species:

rat

Strain:

other:

Remarks:

WISH, substrain: SPF (TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

BOR: WISH, substrain: SPF (TNO)
- Colour: white
- Weight at study initiation: male: 174.3-180 g; female: 154.9-171.7 g
- Fasting period before study: 16 h
- Housing: Macrolon type III/max 5 rats 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)

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Animals were dosed once oral by stomac tubes

- Concentration in vehicle: 50%
- Amount of vehicle (if gavage):3.1-3.7 ml

Doses:

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

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Statistics:

NA

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 other: g/kg bw.

Based on:

test mat.

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

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality, weight changes, clinical signs nor macroscopic findings were observed in male and female rats exposed to the test item (10 g/kg). LD50 is therefore reported as > 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 WISW rats.The rats 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 detected in male and female rats exposed to the test item (10 g/kg). LD50 is therefore reported as > 10 g/kg for both males and females.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

other: Weight of evidence analysis based on expert-evaluated data on the group of lecithins

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: based on expert group reviews and published data

Justification for type of information:

Data on this endpoint are not available for Phosphatidylcholines, soya, hydrogenated. The possible acute dermal toxicity of the substance is therefore assessed in the present weight of evidence analysis based on existing data on the group of lecithins. As the substance belongs to the group of lecithins that are commonly used in cosmetics and used as food ingredient, reviews and expert group assessments of the substances are considered the most valid data for the group of lecithins. In order to combine data on several similar substances, an overall weight of evidence approach is used for the assessment. For more details, please see attached weight of evidence document.

Principles of method if other than guideline:

The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. However, details on methods may vary.
Please refer to attached weight of evidence document.

Specific details on test material used for the study:

For more details, please see attached weight of evidence document.

Species:

rat

Strain:

other: For more details, please see attached weight of evidence document.

Sex:

female

Type of coverage:

not specified

Vehicle:

other: For more details, please see attached weight of evidence document.

Sex:

female

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality observed

Clinical signs:

other: No adverse reactions

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the information available in the present weight of evidence analysis it is concluded that the substance Phosphatidylcholines, soya, hydrogenated is not acutely toxic by dermal route.

Executive summary:

The acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenatedis assessed in a weight of evidence approach using available data on the group of lecithins.

Oral acute toxicity studies on Phosphatidylcholines, soya, hydrogenated in mice and rats determined low toxicity with LD50 > 10 g/kg. Furthermore, several studies of acute toxicity of lecithins and hydrogenated lecithins reported low acute toxicity with LD50 of more than 16,000 mg/kg bw in mice, more than 5,000 mg/kg bw in rats and 4,750 mg/kg bw in rabbits. In a study with phosphatidylserine administrated subcutaneously, the LD50 value was reported to be greater than 5 mg/kg bodyweight. Thus all available studies on acute toxicity by other routes show a low acute toxicity of phosphatidylcholines, soya, hydrogenated and lecithins, with a LD50 of more than 4000 mg/kg bw. Although a relatively high dermal absorption of lecithins have been shown, the potential of acute dermal toxicity is evaluated to be low due to the high LD50 values reported.

Based on the information available in the present analysis it is concluded that the substance Phosphatidylcholines, soya, hydrogenated has low potential for acute toxicity by the dermal route and thus, no classification applies for this end-point.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

The acute oral toxicity of phosphatidylcholine- hydrogenated was investigated in one group of fasted male and female NMRI mice and WISW rats. The mice and rats 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 or macroscopic changes were found in NMRI mice or WISW rats exposed to the test item (10 g/kg). LD50 is therefore reported as > 10 g/kg.

The acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenated is assessed in a weight of evidence approach using available data on the group of lecithins considering the low oral acute toxicity. The overall conclusion based on presented data in the weight of evidence analysis, is that there are no indications of acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenated.

No classification for acute toxicity should therefore apply for Phosphatidylcholines, soya, hydrogenated.