8,9,10-trinorborna-2,5-diene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (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:

8,9,10-trinorborna-2,5-diene

EC Number:

204-472-0

EC Name:

8,9,10-trinorborna-2,5-diene

Cas Number:

121-46-0

Molecular formula:

C7H8

IUPAC Name:

bicyclo[2.2.1]hepta-2,5-diene

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch number of test material: Air Liquide Electronics Materials - Batch No. 10006042
- Purity: 99.8%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability and homogeneity of the test material and during storage: stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by Elevage JANVIER LABS (53940 Le Genest St Isle France)
- Females nulliparous and non-pregnant
- Age at study initiation: 8 weeks old
- Weight at study initiation: mean (6 animals) = 201.3grams
- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: target range of 19°C to 25°C
- Humidity: target range of 30% to 70%
- Air changes: at least ten changes per hour
- Photoperiod: controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
In the first and second step of the study, the test item was administered by gavage under a volume of 2.23 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density) using a suitable graduated syringe fitted with an oesophageal metal canula.

CLASS METHOD (if applicable)
- Dose: The animals of the treated group received an effective dose of 2000 mg/kg body weight of the test item BCHD.
- Rationale for the selection of the starting dose: The highest limit dose according to CLP was tested at first.

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 groups of 3 animals (total of 6 animals during the study)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on D0 (just before administering the test item) then on D2, D7 and D14.
- Necropsy of survivors performed: No, only macroscopics observations were entered on individual autopsy sheets.
- examinations performed: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet. These observations were compared to historical control data. Observations and a mortality report were then carried out every day for 14 days.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Other findings:

No mortality occurred during the study.
A decrease in spontaneous activity (4/6), associated with an increase of salivation (2/6) and piloerection (1/6) were noted during the first hours of the test. The animals recovered a normal activity between 3 and 4 hours post dose.
The body weight evolution of the animals remained normal during the study.
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene is higher than 2000 mg/ kg body weight by oral route in the rat.
The test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.

Executive summary:

The test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423 dated December 17th, 2001 and the test method B. ltris of the Council regulation No. 440/2008.

No mortality occurred during the study.

A decrease in spontaneous activity (4/6), associated with an increase of salivation (2/6) and piloerection (1/6) were noted during the first hours of the test. The animals recovered a normal activity between 3 and 4 hours post dose.

The body weight evolution of the animals remained normal during the study.

The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

In conclusion, the LD50 of the test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene is higher than 2000 mg/ kg body weight by oral route in the rat.

The test item BCHD-Bicyclo 2,2,1-Hepta 2,5 diene does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No signal word or hazard statement is required.