O,O'-dioctadecylpentaerythritol bis(phosphite)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

EC Number:

223-276-6

EC Name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

Cas Number:

3806-34-6

Molecular formula:

C41H82O6P2

IUPAC Name:

3,9-bis(octadecyloxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Weston 619

Test animals

Species:

rat

Strain:

Sherman

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 220 g
- Fasting period before study: 16 hours prior to dose administration
- Housing: individually
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Animals were kept in a conditioned animal room

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 g test material in 5 mL of vegetable oil

Doses:

10,000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No effects were observed at this dose level.

Mortality:

None of the animals died during the study.

Clinical signs:

other: None of the animals showed any signs of toxicity during the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

None of the animals showed any signs of toxicity at the maximum dose that could be given at a single administration. The acute oral LD50 in the rat was therefore determined to be > 10000 mg/kg.

Executive summary:

The acute oral toxicity of the test material was investigated by dosing 5 male and 5 female rats with a single dose of test material by gavage. Following exposure, animals were observed for 14 days. Under the conditions of the study, none of the animals showed any signs of toxicity at the maximum dose that could be given at a single administration. The acute oral LD50 in the rat was therefore determined to be > 10000 mg/kg.