2-methyldecanenitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

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:

Identification: Frutonile
Description: Liquid
Batch Number: VE00002027 or 9000774502
Expiry Date: 19-Oct-2009
Storage conditions: At room temperature (range 20 +/- 5 °C, provided by Harlan Laboratories Ltd.), light protected.
Safety Precautions: Routine hygenic procedures (gloves, laboratory overall, goggles, fask mask). A full filtered, positive air-supplied respirator will be used during the inhalation process.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals: Rat, HsdHan: WIST (SPF)
Rationale: Recognized by international guidelines as recommended test system
Breeder: Harlan Laboratories B.V.
Number of Animals per grop: 5 males and 5 females
Age: Males (10 weeks), Females (12 weeks)
Body Weight range (when treated): 242.0 g - 281.5 g (females), 191.4 g - 220.8 g (males)
Identification: Unique cage number and corresponsing color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total bosy surface. Only animals without injury or irritation to the skin were used in the test. On day one, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 4 ml
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and drapped off with disposable paper towels. Thereafter, the reaction sites were assessed.
All animals were re-shaved on test days 8 and 15 to facilitate the reading of the local reactions

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

Observations:
Viability/Mortality: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15.
Local dermal signs: Once daily during days 2 (following the dressing removal) through day 15 using the numerical scoring system.
Body Weights: On test days 1 (prior to administration), 8 and 15.

Statistics:

No statistical analysis was used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study

Clinical signs:

other: No clinical signs were observed during the course of the study

Gross pathology:

No macroscopic finding were recorded as necropsy.

Other findings:

Local dermal signs: Very slight erythema was observed in all 10 animals on test day 2 after the removal of the application patch and persisted up to test days 6 or 7. Thereafter, all animals were free of local signs up to test day 15, the end of observation time.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of Frutonile after single dermal administration of rats to both sexes, observed over a period of 14 days is:

LD50 (rat) : greater than 2000 mg/kg body weight

Based upon the classification criteria according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Second revised edition, 2007, Frutonile corresponds to Category 5.