1-(1,1-dimethylpropylperoxy)-1-methoxycyclohexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methoxy-1-[(2-methylbutan-2-yl)peroxy]cyclohexane

EC Number:

700-446-2

Cas Number:

125768-93-6

Molecular formula:

C12H24O3

IUPAC Name:

1-methoxy-1-[(2-methylbutan-2-yl)peroxy]cyclohexane

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animais, Boyertown, PA
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 366 - 397 grams for males and 241 - 273 grams for females
- Fasting period before study: yes
- Housing: in suspended wire mesh cages; 5/sex/cage prier to dosing and 3/sex/cage following dosing
- Diet: Fresh PMI Rat Chow, ad libitum
- Water: ad libitum
- Acclimation period:

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.08 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed at 1/2, 1, 2, 3 & 4 hours post-dose and once daily thereafter for 14 consecutive days for mortality, toxicity & pharmacological effects.
Body Weights were recorded immediately pretest, weekly and at death or study termination in the survivors.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

Ali three male and three female animais survived the 2000 mg/kg oral dose.

Clinical signs:

Instances of localized alopecia were the only abnormal physical signs noted during the observation period.

Body weight:

Body weight changes were normal 516 animals. One female lost a slight amount of body weight
between day 7 and day 14.

Gross pathology:

Necropsy results revealed localized alopecia in two. animais and darker than normal kidneys in 5/6
animais. One animal appeared normal during necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD0 is > 2000 mg/kg.

Executive summary:

The potential for oral toxicity of Luperox XPS-TP was evaluated using the Acute Toxic Class Determinationfollowing the OECD Guidelines no. 423. Three healthy male and three healthy female Wistar albino rats were dosed orally with Luperox XPS-TP at 2000 mg/kg. The rats were observed 0.5, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. Abnormal tissues were preserved in 10% neutral buffered formalin for possible future histological examination. All three male and three female animais survived the 2000 mg/kg oral dose. Instances of localized alopecia were the only abnormal physical signs noted during the observation period. Body weight changes were normal 5/6 animals. One female lost a slight amount of body weight between day 7 and day 14. Necropsy results revealed localized alopecia in two animals and darker than normal kidneys in 5/6 animals. One animal appeared normal during necropsy. The LD0 is > 2000 mg/kg.