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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
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.