5-octylbicyclo[2.2.1]hept-2-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 February 2018 to 9 April 2018 (Study initiation to Experimental completion)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-octylbicyclo[2.2.1]hept-2-ene

EC Number:

814-965-8

Cas Number:

22094-84-4

Molecular formula:

C15H18 C15H26

IUPAC Name:

5-octylbicyclo[2.2.1]hept-2-ene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material: Materia Inc.
- Lot/batch No.of test material: RP367_ONB-D
- Expiration date of the lot/batch: 9 August, 2018
- Purity test date: 9 August 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (Ambient), protected from light (as a precautionary measure). Kept in original container, as supplied by the Sponsor.
- Stability under test conditions: Assumed stable for the duration of the study
- Solubility and stability of the test substance in the solvent/vehicle: The test item is a liquid and was tested undiluted..

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan : WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: Minimum: 148.4g Maximum: 181.0g
- Fasting period before study: Rats were fasted overnight prior to dosing and until three hours post-dose.
- Housing: Polypropylene rat cages covered with a stainless steel grid top were used. Autoclaved clean rice husk was used as bedding material. Wooden chew blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
- Water (e.g. ad libitum): UV sterilized water filtered through a Reverse Osmosis water filtration system.
- Acclimation period: 6 to 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 56 to 66%
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod was maintained through an automatic timer)

IN-LIFE DATES: From: To: 7 March 2018 to 9 April 2018 (Experimental start to experimental completion)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: The individual dose volume was adjusted according to body weight, dose level and density but will not normally exceed 10 mL/kg body weight. All rats were dosed by oral gavage (day 0) using a BD 1 mL disposable syringe or Hamilton syringe.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no toxicological information was available on the test item, in accordance with OECD 423, Annex 2c a starting dose of 300 mg 5-octyl-2-norbornene/kg bw was selected as the initial test dose.

Doses:

300 mg 5-octyl-2-norbornene/kg bw
2000 mg 5-octyl-2-norbornene/kg bw

No. of animals per sex per dose:

Twelve females (nulliparous and non-pregnant)
Two set of three female rats doses at 300 mg 5-octyl-2-norbornene/kg bw
Two sets of three females rats doses at 2000 mg 5-octyl-2-norbornene/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5-6 hours post-administration on the day of dosing. Rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes. At the end of the 14 day observation period, all rats were euthanised by carbon dioxide asphyxiation and were subjected to gross pathological examination, consisting of external examination and opening of the abdominal and thoracic cavities.
- Other examinations performed: Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats treated with 300 or 2000 mg 5-octyl-2-norbornene/kg bw

Clinical signs:

No clinical signs were observed in any rat treated with 300 or 2000 mg 5-octyl-2-norbornene/kg bw.

Body weight:

Normal gain in body weight was observed in all rats treated with 300 or 2000 mg 5-octyl-2-norbornene/kg bw.

Gross pathology:

Necropsy (Macroscopic Findings)
External examination of terminally sacrificed rats did not reveal any abnormality.
Internal: Visceral examination of terminally sacrificed rats did not reveal any abnormality.

In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose levels used in the present study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50 cut-off value) 5-octyl-2-norbornene in Wistar rats was found to be 5000 mg/kg body weight.

Based on the results of this study, the classification for 5-octyl-2-norbornene is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017) : Category 5 or Unclassified