Butanoic acid, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 November 2001 - 3 December 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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:

-

EC Number:

441-420-8

EC Name:

-

Cas Number:

113889-23-9

Molecular formula:

C14H20O2

IUPAC Name:

tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl butanoate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl butanoate

Test material form:

liquid

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: approximately 8 weeks
- Weight at study initiation: at least 200g
- Fasting period before study: overnight immediately before dosing, and 3-4 hours after dosing.
- Housing:groups of 3 by sex in solid-floor polyproylene cages furnished with woodflakes.
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by PMI Nutrition International, Nottingham, UK. ad libitium
- Water: ad libitium
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): al least 15
- Photoperiod (hrs dark / hrs light): 12 hrs light, 12 hrs dark. (from 06:00 to 18:00 light)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1,94 ml/kg

RATIONALE FOR THE SELECTION OF THE STARTING DOSE:
- Limit dose of acute toxic method

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to dosing and 7 and 14 days after treatment. Mortality and clinical observations 1/2, 1,2 and 4 hours after dosing and subsequently once daily for 14 days.
- Necropsy of survivors performed: yes, gross necropsy.
- Other examinations performed: no

Statistics:

An estimate of the acute oal median lethal dose (LD50) was made in accordance with the schematic diagram of the acute toxic class method.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: Hunched posture noted in all females. Aditional signs of systemic toxicity noted in one female were ataxia and lethargy. The female recovered one or two days after dosing. No signs of systemic toxicity were noted in males.

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

other: not harmful

Remarks:

in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

The substance has an LD50 of > 5000 mg/kg bw in an OECD TG 423 test.

Executive summary:

In an acute oral toxicity study (according to the acute toxic class method), three males and three females were administered 2000 mg/kg bw Cyclobutanate by gavage. No mortality was observed. Clincal observations were hunched posture in all females, ataxia and lethargy in one female. No signs of systemic toxicity were noted in males. No abnormalities were noted at necropsy.

The acute oral median lethal dose was estimated at >5000 mg/kg bw based on the scheme of the updated OECD TG 423 (2001).