3,7-dimethyloctan-3-yl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloctan-3-yl acetate

EC Number:

244-033-0

EC Name:

3,7-dimethyloctan-3-yl acetate

Cas Number:

20780-48-7

Molecular formula:

C12H24O2

IUPAC Name:

3,7-dimethyloctan-3-yl acetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Remarks:

BR strain (VAF plus)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: mean females:102 g and males 104 g
- Fasting period before study: overnight before dosing
- Housing: groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 44 - 65
- Air changes: air conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: according to OECD guideline 420, not further specified

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg

DOSAGE PREPARATION:
The test article was formulated in corn oil at a concentration of 200mg/mL to achieve a dose level of 2000 mg/kg bodyweight using an individual dose volume of 10mL/kg. All formulations were freshly prepared on the day of dosing.
Rationale for the selection of the starting dose: Results of a range finding study with 500 and 2000 mg/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined shortly after dosing and approximately 30 minutes, one, 2 and 4 hours after dosing for signs of toxicity or changes in appearance or behaviour. Animals were examined daily thereafter for a further 14 days. On the day of dosing all animals were weighed in order to calculate the individual dose volume to be administered. Animals were weighed again on days 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes at the end of the 15 day observation period. The carcasses were subject to a gross necropsy, which included the opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs.

Results and discussion

Preliminary study:

1st female dosed with 500mg/kg bw: Piloerection and hunched posture noted 4 hours after dosing; animal appeared healthy thereafter and survived treatment. 2nd female dosed with 2000mg/kg bw: No apparent effect; animal survived treatment.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

There were no clinical signs of toxicity throughout the observation period.

Body weight:

There was no adverse effect on bodyweight gain in animals of either sex.

Gross pathology:

There were no abnormalities detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of the test, the oral LD50 was > 2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

An acute oral fixed dose study was performed according to OECD TG 420 and in compliance with GLP. 10 Crl: CD (SD) rats (5 male/5 female) were exposed to a single dose of 2000 mg/kg bw test substance by oral gavage. Animals were observed for 14 -days after dosing for clinical signs and body weight gain. After 14 days gross necropsy was performed. No clinical signs of toxicity throughout the observation period were observed and there was no adverse effect on bodyweight gain in animals of either sex. No abnormalities were detected at necropsy. Under the conditions of the test, the LD50 was determined to be > 2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).