Di-tert-pentyl peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Di-tert-pentyl peroxide

EC Number:

234-042-8

EC Name:

Di-tert-pentyl peroxide

Cas Number:

10508-09-5

Molecular formula:

C10H22O2

IUPAC Name:

2-methyl-2-[(2-methylbutan-2-yl)peroxy]butane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: young adult
- Weight at study initiation: 245-277 g (male); 209-223 (female)
- Fasting period before study: overnight
- Housing: The animals were housed individually in suspended stainless steel cages.
- Identifiecation with metal ear tags
- Diet : ad libitum excepting during fasting
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature and Humidity: The animal room temperature and relative humidity ranges were 62-74° F and 52-76%, respectively
- Air changes (per hr): There were 10-15 air changes in the animal room per hour. The animal room temperature and relative humidity were recorded a minimum of once daily. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment
- Photoperiod: 12 hrs dark / 12 hrs light

Protocol Deviations:
The temperature and relative humidity of the animal room (62-74° F and 52-76%, respectively) exceeded the ranges specified in the protocol (65-79° F and 40-70%, respectively) during this study. ln addition, animals were apparently fed expired feed (6/18/95) from day 0 to day 2. These occurrences are considered to have had no adverse effect on the outcome of this study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSE VOLUME APPLIED: 6.17 mL/Kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality check: twice daily, clinical abnomrality observations: once daily. Weighting: prior to exposure, and on day 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: The most notable clinical abnormalities observed during the study included soft stools, decreased defecation, and fecal/urine stain.

Gross pathology:

No significant gross internal findings were observed at necropsy on study day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test, the acute oral LD0 of Di-t-Amyl Peroxide was estimated to be greater than 5000 mg/kg in the rat.

Executive summary:

The Acute oral toxicity of di-tert-amyl peroxide was evaluated in rats in a limit test similar to OECD N°401 guideline. Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14). No mortality occurred during the limit test.  The most notable clinical abnormalities observed during the study included soft stools, decreased defecation, and fecal/urine stain. Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute oral LD0 of Di-t-Amyl Peroxide was estimated to be greater than 5000 mg/kg in the rat.