2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

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:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EEC Commission Directive of 25th april 1984 (pages 96-98 of the document L251)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Commission Directive of 16th September 1983 (L257)

Principles of method if other than guideline:

The method used was designed to meet the requirements of the limit test for acute oral toxicity described on pages 96-98 of the document L251, an EEC Commission Directive of 25th April 1986. This describes the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. The methods of classification used are described by a Directive of 16th September 1983 (L257).

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

Cas Number:

125673-86-1

Molecular formula:

C15H26O

IUPAC Name:

rel-(1R,2R,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

Constituent 2

Reference substance name:

rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

Molecular formula:

C15H26O

IUPAC Name:

rel-(1R,2S,5S)-2-ethoxy-2,6,6-trimethyl-9-methylenebicyclo[3.3.1]nonane

impurity 1

Reference substance name:

4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

EC Number:

250-657-4

EC Name:

4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one

Cas Number:

31499-72-6

Molecular formula:

C13H22O

IUPAC Name:

4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one

Test material form:

liquid

Specific details on test material used for the study:

Test Item: ST 50 C 85 (ST 50 C 85 corresponds to the substance with CAS Nr 68845-00-1 and EC Nr 272-447-1 Boisiris)
Aspect: colourless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult Spragrue Dawley derived rats were supplied by A. Smith, Warlingham Surrey. After arrival at the testing facilities animals were permitted an acclimatisation period of at least five days.

Animals were housed in single sex groups of five in grid bottomed polypropylene cages. A commercially available pelleted rodent diet and mains drinking water via polypropylene bottles were provided ad libitum.

The animal room was illuminated by fluorescent light to give a 24 hour cycle of 12 hours light/12 hours dark. The room was air conditioned with the air temperature maintained within the range 19 °C - 24 °C and relative humidity within the range 49 - 58 % during the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Gum tragacanth

Details on oral exposure:

Following overnight fasting, a group of five male and five female rats were dosed by peroral injection using a rubber catheter attached to a syringe of suitable capacity. After dosing animals were returned to their cages and permitted access to food and water.

Doses:

The material was suspended in a 0.25% aqueous solution of gum tragacanth to give a dose volume of 10 ml/kg at a dose level of 5.0 g/kg.

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

All animals were examined frequently 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.

At the end of the fourteen day port dose observation period all animals were weighed and then sacrificed by carbon monoxide asphyxiation. The animals were then subjected to gross examination including the opening of the cranial, thoracic and visceral cavities.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

Not specified.

Other findings:

Not specified.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material had no toxic effect when administered as a single oral dose to the rat. The results demonstrate that the median lethal dose (LD50) of the test material on an oral ingestion is in excess of 5.0 g/kg bodyweight and the material would thus not require classification as harmful.

Executive summary:

Rat oral LD50 >5000 mg/kg bw.