3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 March to 9 August 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with internationally recognised guideline

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The study was designed to evaluate the acute toxicity of PEP-36 following a single oral dose to rats according to Environmental Protection Agency, Toxic Substances Control Act Test Guidelines, 40 CFR Part 798, Subpart B, 1985.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,9-bis(2,6-bis(1,1-dimethylethyl)-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

IUPAC Name:

3,9-bis(2,6-bis(1,1-dimethylethyl)-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test animals

Species:

other: Rat Crl : SD

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Huile de maïs

Doses:

Range finding: 50, 100, 1000, 2500,and 5000 mg/kg of body weight,
Main study: 5000 mg/kg of body weight

No. of animals per sex per dose:

Range finding study: 1
Main study: 5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Des fécés molles (2/10) sans valeur toxicologique et coloration de l'urine de 3/10 réversible au jour 2. Aucun autre signe lié au traitement n'a été remarqué.

Gross pathology:

Effects on organs:
On a observé une décoloration du foie (3/10) et des reins
(2/10) et des contenus anormaux dans les intestins dans 2
femelles et 4 mâles.


Intestins contenant un liquide jaune (3/10) ou rouge( 2/10)
ou pâteux (1/10)

Any other information on results incl. tables

In the Single Dose Study (5000 mg/kg of body weight), clinical observations consisted of urine stains and soft faeces. No observable gross pathology findings were noted in two males and one female; while, observable gross pathology findings in the remaining animals involved the liver and kidneys (discolored) and intestines (abnormal contents).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the results of the study, the acute oral LD50 was estimated to be greater than 5000 mg/kg of body weight in male and female and combined male and female rats.