3-Oxabicyclo[4.1.0]hept-4-en-2-one, 4,7,7-trimethyl-, (1R,6S)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1999 - March 1999

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1R,6S)- 4,7,7-Trimethyl-3-oxabicyclo[4.1.0]hept-4-en-2-one

Cas Number:

70174-49-1

Molecular formula:

C9H12O2

IUPAC Name:

(1R,6S)- 4,7,7-Trimethyl-3-oxabicyclo[4.1.0]hept-4-en-2-one

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Males: 223-240g, females: 202-211g
- Fasting period before study: overnight
- Housing: solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water (e.g. ad libitum): See above
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 46-59
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

One dose by gavage, using a metal cannula attached to a graduated syringe

Doses:

The toxicity information available suggested that mortality was unlikely at the maximum dose leve. therefore the animals were treated with 2000 mg/kg

No. of animals per sex per dose:

3 females + 3 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: ½, 1, 2, 4 hours after dosing and then once daily for 14 days.
- Frequency of weighing: At day 0 (Day of dosing), on day 7 +14.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs: Signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and ataxia, developing on the day of dosing and lasting up to one day after dosing.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and ataxia, developing on the day of dosing and lasting up to one day after dosing.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.