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

Endpoint summary

Description of key information

The acute lethal oral dose to rats was found to be: greater than 5.0 g / kg bodyweight
The acute lethal dermal dose to rats was found to be: greater than 2.0 g / kg bodyweight
The acute inhalation study is waived because of low vapour pressure and low exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Species:

other: Rat Crl : SD

Strain:

Sprague-Dawley

Sex:

male/female

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

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)

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).

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

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:

experimental study

Adequacy of study:

key study

Study period:

10 September to 16 October 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with internationally recognised guideline

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/CEE - B3

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

other: Rat Wistar

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

other: Polyéthylène-glycol

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Aucun signe de toxicité n'a été observé pendant l'essai.

Gross pathology:

Effects on organs:
Aucune anomalie n'a été observée à l'examen macroscopique
post mortem à la fin de l'étude.

Other findings:

Signs of toxicity (local):
On a noté aucune irritation de la peau pendant l'essai.

No mortality occurred during 15 days of observation.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Toxicity was estimated to be greater than 2000 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – inhalation endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

The oral and dermal studies return LD50's of 5.0 and 2.0 g / kg bw and the inhalation study is waived on grounds of low vapour pressure and low exposure. Therefore, the substance is not classified for acute toxicity.