Bis(3,5,5-trimethylhexanoyl) peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Valid with restriction; meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

bis (3,5,5-trimethylhexanoyl) peroxide

IUPAC Name:

bis (3,5,5-trimethylhexanoyl) peroxide

Constituent 2

Reference substance name:

Trigonox 36 - CD75

IUPAC Name:

Trigonox 36 - CD75

Constituent 3

Reference substance name:

Bis(3,5,5-trimethylhexanoyl) peroxide

EC Number:

223-356-0

EC Name:

Bis(3,5,5-trimethylhexanoyl) peroxide

Cas Number:

3851-87-4

Molecular formula:

C18H34O4

IUPAC Name:

3,5,5-trimethylhexanoyl 3,5,5-trimethylhexaneperoxoate

Details on test material:

- Name of test material (as cited in study report): Trigonox 36-CD 75 (bis(3,5,5-trimethylhexanoyl peroxide)
- Substance type: organic peroxide
- Physical state: clear colourless liquid
- Analytical purity: 75 % in isododecane
- Storage condition of test material: -20°C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: TNO
- Age at study initiation: young adults
- Weight at study initiation: males: 182-322 g, females: 140-230 g
- Fasting period before study: overnight
- Housing: goups of 5
- Diet (e.g. ad libitum): after treatment ad libitum
- Water (e.g. ad libitum): after treatment ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

75% solution in isododecane

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml per kg bodyweight

Doses:

11.6, 13.9, 16.7, and 20 ml per kg bodyweight

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: no data
- Necropsy of survivors performed: yes

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 12.7 mL/kg bw

Based on:

test mat.

95% CL:

>= 9.3 - <= 17.3

Mortality:

Mortality of the doses tested: 40-90 % (see Table 1); most death occured between 17 hours and 6 days after treatment; two males died on day 8 and 9

Clinical signs:

other: sluggishness, humpback behaviour and severe diarrhoea; irritation of the skin in the area around anus and tailroot, encrustations around eyes and nostrils; at the end of the observation period some rats showed necrosis of the skin around anus and tailroot

Gross pathology:

no treatment-related gross alterations

Any other information on results incl. tables

Table 1: Dosis applied and mortality observed

Dose ml/kg	Mortality (No. of died per total animals per dose)
	males	females	% of mortality
11.6	3/5	1/5	40
13.9	3/5	3/5	60
16.7	5/5	4/5	90
20	5/5	3/5	80

The LD50 was calculated according to the method of Weil (Biometrics 8 (1952) 249 -263).

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of bis-(3,5,5-trimethylhexanoyl)peroxide (75% in isododecane) was calculated to be 12.7 ml which equates to 11.96 g/kg bw.

Executive summary:

In an acute oral toxicity study, groups of fasted, young adult Wistar derived male and female rats (5 per sex and dose) were given a single oral dose of  bis-(3,5,5-trimethylhexanoyl)peroxide in 75% isododecane at doses of 11.6, 13.9, 16.7 and 20 ml/kg bw by gavage and were observed for 14 days. The LD50 was calculated to be 12.7 ml per kg body weight (which equates to 11.96 g/ kg bw) with 9.3 and 17.3 as the 95 % confidence limits.

Bis-3,5,5 -trimethylhexanoyl peroxide in 75% isododecane is practically non-toxic. This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study in the rat.