Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

purity not indicated, body weighs not given, no data for individual animals

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data for single animals, body weight not recorded.

Principles of method if other than guideline:

20 young adult rats were used in this study to determine the range of toxicity. The material was administered to ether-sedated fasted animals as a suspension in DMSO/corn oil (50/50) heated to 50 °C. Controls were given DMSO/corn oil (50/50) only. The dose was given intragastrically with a ball-tipped needle and syringe. After treatment, all animals were observed daily for 30 days for aberrant physiological and behavioral responses

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

EC Number:

229-722-6

EC Name:

Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Cas Number:

6683-19-8

Molecular formula:

C73H108O12

IUPAC Name:

3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Specific details on test material used for the study:

- Storage condition of test material: 25 °C in a glass container sealed inside a polyethylene bag

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 67 days
- Weight at study initiation: 250 - 270 g
- Fasting period before study: Yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: DMSO/corn oil (50/50)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Justification for choice of vehicle: Insoluble in water

DOSAGE PREPARATION (if unusual): 5 g of test material were dissolved in 5 mL of DMS0 at 50 °C. This solution was diluted with 5 mL of corn oil, which formed a suspension of the test substance in the liquid medium. This suspension was kept at 50 °C until administration was completed.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Preliminary study

Doses:

5 g/kg

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 30 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: aberrant physiological and behavioral responses

Results and discussion

Preliminary study:

Because the LD50 was greater than 5 g/kg, the material was considered to be nontoxic.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Mortality:

none

Clinical signs:

other: The report gives a general assessment that all behavioural and physiological responses were normal.

Gross pathology:

not mentioned

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Because the LD50 was greater than 5 g/kg, the material was considered to be nontoxic.