Isooctene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP, guideline study, fully adequate for assessment

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:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctene

EC Number:

234-294-9

EC Name:

Isooctene

Cas Number:

11071-47-9

Molecular formula:

C8H16

IUPAC Name:

2-methylhept-1-ene

Constituent 2

Reference substance name:

Di-n-butene

IUPAC Name:

Di-n-butene

Details on test material:

Di-n-butene. According to the report's owners the substance di-n-butene can be classified as CAS 11071-47-9 (Isooctene)
Components: 18% n-Octene, 58% Methylheptene and 24% Dimethylhexene

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF TNO
- Weight at study initiation: 118.6 g
- Fasting period before study: 16 hours
- Housing: stainless steel cages
- Diet: R10 Alleindiat for rats ad libitum
- Water: tap water ad libitum
- Acclimatisation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±1°C
- Humidity: 60±5%
- Air changes: 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

13699 cm3/kg

No. of animals per sex per dose:

5 per sex (total 10)

Control animals:

no

Details on study design:

- Animals were randomly allocated to stainless steel cages
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at 6 hours after dosing and daily. Animals were weighed at 1, 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy with macroscopic examination

Statistics:

LD50 calculated following Litchfield and Wilcoxon method with 95% confidence intervals.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

None

Clinical signs:

other: After one hour the animals exhibited piloerection. Then animals crouched, had slight tremors, diuresis, lightly coloured faeces with a strong smell of the test substance. After 48 hours the animals were free of these clinical signs.

Gross pathology:

One animal had partial thickening of the forestomach and another had partial hyperaemia of the small intestine membrane.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of di-n-butene in rats was >10,000 mg/kg. Animals were free of clinical signs after 48 hours. At necropsy, one animal had partial thickening of the forestomach and another had partial hyperaemia of the small intestine membrane.

Executive summary:

Following a single oral dose of 10,000 mg/kg, none of the animals died. The LD50 of di-n-butene in rats was >10,000 mg/kg.