methylethylketone peroxide trimer

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - May 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-320-2

EC Name:

-

Cas Number:

24748-23-0

Molecular formula:

C12H24O6

IUPAC Name:

3,6,9-triethyl-3,6,9-trimethyl-1,2,4,5,7,8-hexaoxonane

Constituent 2

Reference substance name:

Initiator D-129

IUPAC Name:

Initiator D-129

Details on test material:

Batch no. 1400-005
Storage at ca. 4 degr. C
42% peroxide in mineral spirit

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals and Animal Husbandry
Male and female Sprague-Dawley CD (Cri : CD ® BR) strain rats supplied by
Charles River (UK) Ltd., Margate, Kent, UK. were used. At the start of the main
study the males weighed 204 to 219g, and the females 204 to 228g, and were
eight to twelve weeks of age. After an acclimatisation period of at least five
days the animals were selected at random and given a number unique within
the study by indelible ink-marking on the tail and a number written on a cage
card.

The animals were housed in groups of up to five by sex in solid-floor
polypropylene cages furnished with woodflakes. With the exception of an
overnight fast immediately before dosing and for approximately three to four
hours after dosing, free access to mains drinking water and food (Rat and
Mouse Expanded Diet No.1, Special Diets Services limited, Witham, Essex,
UK) was allowed throughout the study.

The animal room was maintained at a temperature of 19 to 24· C and relative
humidity of 47 to 54%. The rate of air exchange was approximately fifteen
changes per hour and the lighting was controlled by a time switch to give
twelve hours continuous light and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

2.27 ml/kg bw was given; with a density of 0.882, this resulted in 2000 mg/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other:

Details on study design:

All animals were dosed once only by gavage using a metal cannula attached
to a graduated syringe. The volume administered to each animal was
calculated according to its fasted bodyweight at the time of dosing.

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and
4 hours after dosing and subsequently once daily for fourteen days.
Individual bodyweights were recorded prior to dosing on Day 0 and on
Days 7 and 14.

At the end of the study the animals were killed by cervical dislocation and
subjected to gross pathological examination. This consisted of an external
examination and opening of the abdominal and thoracic cavities for
examination of major organs. The appearance of any macroscopic

Evaluation of Data

Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.

Using the mortality data obtained, an estimate of the acute oral median lethal
dose (LD50) of the test material was made .
abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

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: In two females hunched posture and lethargy was observed two hours to one day after dosing. All animals were normal on day 2.

Gross pathology:

Effects on organs: No abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 in rats is greater than 2000 mg/kg.

Executive summary:

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method 81 of Commission Directive 92169/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material, at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.