3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate

EC Number:

413-910-1

EC Name:

3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate

Cas Number:

1467668-33-2

Molecular formula:

C16H32O4

IUPAC Name:

4-hydroxy-2-methylpentan-2-yl 2-ethyl-2-methylheptaneperoxoate

Details on test material:

- Purity: 90.5 %
- colourless liquid
- The test substance was initially stored at -20°C and protected from light.
- The test substance was stored at +4°C until the treatment.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMAL
- Source: Iffa Credo (69210 L'Arbresle, France)
- Age: 6 weeks
- Weight at study initiation: 174 ± 9 g (males) and 150 ± 3 g (females)
- Upon their arrival at the laboratory, the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily.
- Animals were individually identified by earmarks or earnotches
- Diet: ad libitum
- Food: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- The animals were housed in groups of 4 to 7 animals of the same sex during the acclimatization period and groups of 5 animals of the same sex during the study.
- The day before treatment, the animals were fasted for a period of approximately 18 hours before administration of the test substance. They were then given food 4 hours after treatment.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: none

Details on oral exposure:

- Volume administered: taking into consideration the specific gravity of the test substance (0.96)
- Post dose observation period: 14 days

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Clinical signs: examined at least once a day
- Mortality: recorded at least twice a day
- Body weight: measured just before administration then on days 5, 8 and 15.
- Necropsy: . macroscopic examination of the main organs: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities.
- Microscopic examination: no

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Mortality:

No deaths occurred during the observation period.

Clinical signs:

other: No clinical signs were observed during the study.

Other findings:

NECROPSY FINDINGS: No apparent abnormalities.
Due to the absence of macroscopic lesions, no organ samples were taken and no histological examination was performed.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Under the experimental conditions, the LD0 of the test substance administered by oral route in rats was higher than 2000 mg/kg. No signs of toxicity were observed at this dose level.

Executive summary:

The test substance was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females) in an acute toxicity test by oral route (OECD 401, GLP).

The test substance was administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity of the test substance was .96.

The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.

The general behaviour and body weight gain of the animals were not influenced by the treatment. No deaths occurred at the dose level of 2000 mg/kg. The macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.