1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 October 1992 - 6 November 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed according to OECD guidelines and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)

EC Number:

235-935-5

EC Name:

1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)

Cas Number:

13052-09-0

Molecular formula:

C24H46O6

IUPAC Name:

5-[(2-ethylhexanoyl)peroxy]-2,5-dimethylhexan-2-yl 2-ethylhexaneperoxoate

Details on test material:

Name: Trigonox 141
CAS No.: 13052-09-0

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 (U.K.) Limited, Margate, Kent, England
- Age at study initiation:5 weeks
- Weight at study initiation: males from 116 - 138 g and for females from 116 - 131 g.
- Fasting period before study: removal of food for approximately 18 hours before administration of the test material.
- Housing: The animals were housed in stainless steel grid cages (Stephen Clark Fabrications Limited, Alva, Clackmannanshire, Scotland).
- Diet (e.g. ad libitum):ad libitum, commercially-available complete pelleted rodent diet (RM-1 S.Q.C., from Special Diets Services Limited, Witham, Essex, England)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 38-57
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: 14 October 1992 - 6 November 1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage): 10ml/kg

DOSAGE PREPARATION (if unusual): The dosage was calculated and expressed gravimetrically in terms of the material as received. A fresh formulation of the test material was prepared shortly before administration and any surplus remaining after dosing was destroyed on the same day

Doses:

2000 mg/kg bw

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: Three separate inspections were made during the first hour after dosing and two further inspections during the remainder of Day 1. From Day 2 onwards the animals were inspected twice daily (morning and afternoon). The type t time of onset and duration of reactions to treatment were recorded. The bodyweight of each animal was recorded on the day before dosing and on Days It 8 and 15. The test was terminated on the morning of Day 15
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities

Mortality:

There was no death.

Clinical signs:

other: There was no sign of reaction to treatment.

Gross pathology:

Necropsy, on Day 15, revealed no significant macroscopic lesion.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg. The animals were starved overnight prior to dosing and the test material was administered at a constant volume-dosage of 10 ml/kg in maize oil. Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy. There was no death and no sign of reaction to treatment. The animals achieved expected bodyweight gains and necropsy

revealed no significant macroscopic lesion. Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.