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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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.
Body weight:
No effect on bodyweight
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.