2-methyldecanenitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The United States of America Code of Federal Regulations (EPA-TSCA) Toxic Substances Control Act CFR 40 Part 792 (Volume 48 No. 230 November 29th 1983).

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methyldecanenitrile

EC Number:

273-960-3

EC Name:

2-methyldecanenitrile

Cas Number:

69300-15-8

Molecular formula:

C11H21N

IUPAC Name:

2-methyldecanenitrile

impurity 1

Reference substance name:

Unknown impurities

Molecular formula:

Unknown

IUPAC Name:

Unknown impurities

Specific details on test material used for the study:

Aspect: colourless clear liquid
Label: ST 21 C 89 (Statement from Firmenich confirms that ST 21 C 89 corresponds to the substance with CAS Nr 69300-15-8 and EC Nr 273-960-3)
Storage: in the dark at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl: CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult Sprague Dawley derived rats of the Crl: CD(SD)BR strain were supplied by Charles River (UK) Ltd, Margate, Kent and were delivered by road transport on 1st September 1989. Animals were allowed an acclimatisation period of 6 days.

Animals were housed in single sex groups of five in grid bottomed polypropylene cages. A commercially available pelleted rodent diet (SQC R and M No. 1 expanded, produced by Special Diets Services, Witham, Essex) and mains drinking water via polypropylene bottles were provided ad libitum except during the pre-dose overnight fasting period , when water only was available. Certificates of analysis for both diet and drinking water are held on file at Toxicol Laboratories.

The animal room was illuminated by fluorescent light to give a 24 hour cycle of 12 hours light/12 hours dark and the room was air conditioned with the air temperature maintained within the range 18-22 °C and relative humidity within the range 51-75% during the acclimatisation and study periods.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Healthy animals were fasted overnight prior to dosing. Five male and five female animals were selected for treatment and weighed, the weight being used to caluclate the amount of material to be administered at a dose volume of 10 ml/kg and a dose level of 2000 mg/kg. Animals were dosed with the prepared test material by peroral injection using a metal cannula attached to a syringe of suitable capacity. After dosing animals were returned to their cages and permitted access to food.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 aminals per sex per dose

Control animals:

not specified

Details on study design:

Observations:
All animals were examined at approximately 30 minutes and 1, 2 and 4 hours after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.

Necropsy:
At the end of the fourteen day post-dose observation period, surviving animals were weighed and then sacrificed by carbon dioxide narcosis. All cadavers were subjected to gross examination including the opening of the thoacic and visceral cavities. In addition the stomach and representative sections of the gastro-intestinal tract were examined.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

One male was found dead on Day 4 of the study and surviving males exihibited piloerection from Day 5 until Day 8. No other signed of toxicity were noted throughout the study. At necropsy, kidney dilation was noted in one male and one female animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, ST 21 C 89, produced some toxic effect in rats, following oral administration of a single dose of 2000 mg/kg bw, causing death in one of the 10 animals dosed, but the results indicate that the LD50 of the test material is significantly above this level.