tert-pentyl 2-ethylperoxyhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2a Guideline study without detailed documentations (no certificat of analysis for example)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

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:

tert-pentyl 2-ethylperoxyhexanoate

EC Number:

211-687-3

EC Name:

tert-pentyl 2-ethylperoxyhexanoate

Cas Number:

686-31-7

Molecular formula:

C13H26O3

IUPAC Name:

2-methylbutan-2-yl 2-ethylhexaneperoxoate

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Sprague Dawley rats, 200-300 g at arrival
- Acllimation periode: 5 days
- Housing: individually
- Fasting overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- All animals were weighted prior to exposure, and at termination.
- Animals were observed daily for 15 days, all gross visible and pharmacological effects were reported.
- No necropsy was performed since no animal died

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: All the animals exhibited decreased activity the two or three first days after treatment. Some of them had for one or two days wet, yellow belly

Gross pathology:

Not observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD0 of tert-amyl peroxyoctotate in rats is more than 5000 mg/kg.

Executive summary:

The acute oral toxicity of tert-amyl peroxyoctoate was evaluated in a limit test in rats according to a procedure similar to OECD N°401 guideline (Acute Toxic Standard Method) and in compliance with GLP. 10 male and 10 female Sprague Dawley rats were given a single oral dose (5000 mg/kg) of tert-amyl peroxyoctoate. Following treatment, rats were observed daily and weighted at termination. No gross necropsy examination was performed since no mortality occured and since clinical signs (especially decreased activity) were observed only the first days after dosing.

  

Under these experimental conditions, the oral LD0 of tert-butyl peroxyoctoate is more than 5000 mg/kg in Sprague Dawley rats.