Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction

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

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

11071-47-9

Molecular formula:

C8H16

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 (e.g. ad libitum): R10 Alleindiat for rats
- Water (e.g. ad libitum): tapwater
- Acclimation period: 4-8 days


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

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:

LC50 calculated following Litchfield and Wilcoxon method with 95% confidence intervals

Results and discussion

Effect levels

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 partial hyperemia of the small intestine membrane.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

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 partial hyperemia of the small intestine membrane.