1,1,3,3-tetramethylbutyl peroxyneodecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 May 1986 - 11 June 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

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:

1,1,3,3-tetramethylbutyl peroxyneodecanoate

EC Number:

257-077-0

EC Name:

1,1,3,3-tetramethylbutyl peroxyneodecanoate

Cas Number:

51240-95-0

Molecular formula:

C18H36O3

IUPAC Name:

2,4,4-trimethylpentan-2-yl 2,2,3,5-tetramethylhexaneperoxoate; 2,4,4-trimethylpentan-2-yl 2,2-diethylhexaneperoxoate; 2,4,4-trimethylpentan-2-yl 2,2-dimethyloctaneperoxoate; 2,4,4-trimethylpentan-2-yl 2,4-dimethyl-2-(propan-2-yl)pentaneperoxoate; 2,4,4-trimethylpentan-2-yl 2-ethyl-2,5-dimethylhexaneperoxoate

Details on test material:

- Chemical name: Neodecane peroxoic acid 1,1,3,3-tetramethyl butyl ester
- Appearance: Colouless clear liquid
- CAS-reg. no.: 51240-95-0

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Credo, Brussels, Belgium. Date of arrival at the animal house
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: The body weights of the males on day 0 ranged from 304 to 332 g and those of the females from 200 to 247 g.
- Fasting period before study: Feed was withheld overnight before dosing till approximately 4 hours after administration of the test substance
- Housing: individually housed in polycarbonate cages
- Diet (e.g. ad libitum): ad libitum (standard laboratory animal diet (RMH-B, pellet diameter 10 mm))
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 50-95
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 21 May 1986 - 11 June 1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
The test substance was administered as a single dose using a stainless steel stomach cannula. Prior to dosing the test substance was removed from storage and was kept on ice until dosing. The dose volume was 5.7 ml/kg body weight. The day of dosing was considered as day 0.

Doses:

5000 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: Cage-side observations were performed on the day of dosing (approximately once every two hours) and daily thereafter. With exception of weekends and holidays a mortality check was performed at the end of the day. Individual body weights (with group means and standard deviation) were measured weekly. At the end of the study (day 14) all surviving animals were sacrificed by CO2-asphyxation and subjected to autopsy.
- Necropsy of survivors performed: yes
- Other examinations performed: None

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred.

Clinical signs:

other: No signs of systemic toxicity were observed during the 14-day observation period.

Gross pathology:

Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg bw

Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, received a single oral dose of the test substance at 5000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. Weekly group mean body weight gain was normal. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 5000 mg/kg bw.