OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate

EC Number:

252-029-5

EC Name:

OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate

Cas Number:

34443-12-4

Molecular formula:

C13H26O4

IUPAC Name:

3-({[(tert-butylperoxy)carbonyl]oxy}methyl)heptane

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, Brussel, Belgium
- Young animals
- Weight at study initiation: 281.9 +-7 (male)/ 208.8+-8 (female)
- Fasting period before study: 12 hours before, and 4 hours after gavage
- Housing: individually in Macrolon cages
- Diet and water ad libitum
- Acclimation period: 6 days
- Quarantine period of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 25-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

5.405 mL/Kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Preliminary study:

Dose range finding study with one male and one female, at following doses: 1800, 2400, 3200, 4200, 5000 mg/kg : no mortality, no clinical signs excepted diarrhea, no gross abnormalities at necropsy.

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: diarrhea for 9 animals the two first days

Gross pathology:

no effect

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD0 of TBEC more than 5000 mg/kg in Sprague Dawley rats.

Executive summary:

The Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). 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).

There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities.

Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.