Oleonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Feb. 1987 - 6 Mar 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to adequate guideline and adequately reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Guideline:

other: FIFRA - Acute oral - Limit test (40 CFR 798)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oleonitrile

EC Number:

204-016-0

EC Name:

Oleonitrile

Cas Number:

112-91-4

Molecular formula:

C18H33N

IUPAC Name:

(9Z)-octadec-9-enenitrile

Constituent 2

Reference substance name:

Oleylnitrile

IUPAC Name:

Oleylnitrile

Details on test material:

Arneel OD: !00% Oleylnitrile CAS 112-91-4
Lot no.: 1512704
Received: 18 Feb. 1987
Dark yellow liquid.
Stored at room temperature in clear glass jar
No other information included in report

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Age at study initiation: young adults
- Weight at study initiation: 154-244 g at start study
- Fasting period before study: overnight
- Housing: Singly in stainless steel wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum: PURINA LABORATORY CHOM
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not indicated
- Humidity (%): not indicated
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 19 Feb 1987 - 6 Mar 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Test material was administered once undiluted at 5 g/kgbw by esophageal intubation.

Doses:

undiluted at 5 g/kgbw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Animals were observed for gross signs of systemic toxicity and mortality several times (more often if animals exhibited definite signs of toxicity) during the day of dosing, and at least twice daily for a total of 14 days.
The observation and times of observation were documented. Animals were weighed on the day of dosing and seven days after treatment. At the end of the observation period, the animals were sacrificed by carbon dioxide inhalation, weighed, dipped ten times in isopropanol, and given a gross necropsy. The isopropanol was evaporated and the residue sent to the sponsor. All observations were doewnented, but tissues were not saved.

Statistics:

not applicacble: Depending on results of study, the matial is placed in one of the classifications for hazard rating potential (40 CFR 156, Proposed):
Category I - Up to and including 50 mg/kg
Category II - Greater than 50 mg/kg thru 500 mg/kg
Category III - Greater than 500 mg/kg thru 5000 mg/kg
Category IV - Greater than 5000 mg/kg.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the 14-day observation period

Clinical signs:

other: Clinical signs generally observed up to the end of the 14-day period in all animals, consisted of pilo-erection, urine stains, scruffy hair coat, red-brown stains around the nose, coats oily on the dorsal side, alopecia on the back (one female, two males)

Gross pathology:

The left kidney of one female appeared slightly hollowed. There were no other gross pathological changes noted in the remaining
animals.

Other findings:

No organ weights of histopathology was performed. No other findings are reported.

Any other information on results incl. tables

Body weight Data:

Sex	Body weight (gain) in gram
	Day 0	Day 7	Day 14	Gain 1-14
M	231	279	308	77
M	230	269	295	65
M	243	286	327	84
M	244	280	325	81
M	237	268	298	61
Mean	237	276	311	74
SD	7	8	15	10
F	172	189	210	38
F	170	214	244	74
F	162	206	224	62
F	172	199	213	41
F	154	186	203	49
Mean	166	199	219	53
SD	8	12	16	15

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute lethal oral dose to rats was found to be > 5000 mg/kg.

Executive summary:

Oleylnitrile of technical pure quality was tested for acute oral toxicity at a dose level of 5000 mg/kg to groups of five female and five male rats. The animals were observed up to14 days after dosing for mortality, clinical signs, body weight and post mortem examination.

There were no mortalities observed. Body weight gain was normal during the 14 -day observation period for all groups.

Clinical signs were generally observed up to the end of the 14-day period in all animals, and consisted of pilo-erection, urine stains, scruffy hair coat, redbrown stains around the nose, coats oily on the dorsal side, and areas of alopecia on the back or hind legs.

Terminal autopsy findings were normal except for the left kidney of one female that appeared slightly hollowed.

Conclusion: The acute lethal oral dose to rats was found to be > 5000 mg/kg.