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Description of key information

In an acute oral toxicits study with TBPPI in rats a combinded LD50 value of 4169 mg/kg bw was determined. The 4 hours LC50 was calculated to be 7.79 mg/l with 95 % confidence limits of 5.89 and 10.28 mg/L (exposure to mist). In an acute dermal toxicits study with TBPPI in rabbits a LD50 value of 2500 mg/kg bw was determined.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4 169 mg/kg bw
Quality of whole database:
reliable with restrictions

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
7 790 mg/m³
Quality of whole database:
reliable with restrictions

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
reliable with restrictions

Additional information

Oral:

Twenty-five male and twenty- five female rats of the Sprague Dawley strain were used for an acute oral toxicity study. The test material was administered orally by gavage as a solution in corn oil at the following dosage levels to male and female rats: 1585; 2512; 3980 and 10000 mg/kg bw. Five rats of each sex were used at each dosage level. All the dosage levels were administered at a volume of 10 mL/ kg except for the high dose, which was administed at a volume of 20 mL/kg.

The rats were observed for mortality, only, during the first four hours following dosing, at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded immediately prior to dosing and at 7 and 14 days.

No animal died at the two lowest dosage levels. Four females died at the dosage level of 3,980 mg/kg bw and all animals died in the two highest dosage levels.

The combined male and female acute oral LD50 value was 4169 mg/kg bw and the 95th confidence interval was 3587 - 4845 mg/kg bw.

 

Inhalation:

Tert-butyl peroxypivalate was tested in an acute inhalation toxicity study. Four groups of 5 male and 5 female rats were exposed to an aerosol atmosphere of tert-butyl peroxypivalate. The four "metered" concentrations were 17.1, 8.3, 4.2, 2.0 mg/L respectively. Slight to marked dyspnea and deaths were observed in all groups of rats at concentrations above 2.0 mg/L. All rats lost weight following the exposures. Necropsy of the dead rats revealed reddened lungs with dark red patches and discoloration of the liver. The 4 hours LC50 was calculated to be 7.79 mg/L with 95 % confidence limits of 5.89 and 10.28 mg/L. Furthermore, an acute inhalation toxicity study, published by Gage J.C. (1970) is available. Tert- butyl peroxypivalate was irritant to the eyes and respiratory tract but no mortality was observed with a concentration of 200 ppm (corresponding to 1.45 mg/L).

Dermal:

Twenty male and twenty female New Zealand White rabbits were used for an acute dermal toxicity study with TBPPI. The rabbits were divided into five groups of 2 male and 2 female rabbits each. The hair was removed from the back of each rabbit (20 -30% of the body surface) with an electric clipper. The test material was applied once only to the backs of the rabbits at the following dosage levels: 1250; 2500; 5000; 10000 and 20000 mg/ kg bw. Following dosing, the application sites were wrapped with gauze bandaging and overwrapped with Saran Wrap. 24 hours following application, the bandages were removed and the test sites were washed with tepid tap water. The rabbits were observed at 24 hours and daily thereafter for a total of 14 days for pharmacotoxic signs, mortality and dermal irritation. Body weights were recorded immediately prior to the test material administration and at 7 and 14 days of the observation period. All rabbits which died on study were subjected to gross necropsy examination.

All animals exposed to 5000 mg/kg bw and higher died during the testing period. One female and one male rabbit died in the lowest and the 2500 mg/kg bw dose level respectivly. In all surviving animals moderate to marked dermal irritation and necrosis occured and were not reversible until 14 days. Necropsy of died animals showed ulceration and hyperemia of the mucosa of the stomach and discoloration of the liver. No adverse effects on body weights of surviving animals could be observed.

The acute dermal LD50 values were 2500 mg/kg bw in males and females and the 95th confidence limits were 1250 - 5000 mg/kg bw in males and 625- 10000 mg/kg bw in females.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
No guideline study available. Key study is of recent date.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Based on Regulation (EC) No 1272/2008 (CLP), TBPPI is not classified for acute oral, dermal and inhalation toxicity. The substance contains up to 26 % isododecane as stabilizer which is classified as aspiration toxicity cat. 1. Based on the kinematic viscosity of the substance and in accordance with the section 3.10.3 of Annex I of Regulation (EC) No 1272/2008 (CLP) the substance have to be classified with as aspiration toxicity cat. 1, H304: May be fatal if swallowed and enters airways.

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