Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2001-02-20 to 2011-03-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide

EC Number:

213-944-5

EC Name:

Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide

Cas Number:

1068-27-5

Molecular formula:

C16H30O4

IUPAC Name:

2,5-bis(tert-butylperoxy)-2,5-dimethylhex-3-yne

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Wistar strain Crl:(WI) BR (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Weight at study initiation: Body weight variation did not exceed ± 20 % of the sex mean.
- Fasting period: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per sex per cage in labelled Macrolon cages (type IV; height 15 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Identification: Earmark
- Diet: Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany)
- Water: Free access to tap-water
- Acclimation period: at least 5 days before start of the treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 15 per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Single dosage of 2000 mg/kg (1.55 mL/kg) bw

No. of animals per sex per dose:

3 animals per sex (females were nulliparous and non-pregnant)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations:
Body weights: Day 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

other: Lethargy, hunched posture, piloerection, and/or ptosis were noted among the animals between days 1 and 3. Lethargy, rales and salivation were noted in one male on day 12. Two males showed alopecia (throat region) before commencement of the study and durin

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, an LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 423, test item was administered by oral gavage to groups of 3 Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Lethargy, hunched posture, piloerection, and/or ptosis were noted among the animals between days 1 and 3. Lethargy, rales and salivation were noted in one male on day 12. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg bw.