Isobutyl isobutyrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

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 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl isobutyrate

EC Number:

202-612-5

EC Name:

Isobutyl isobutyrate

Cas Number:

97-85-8

Molecular formula:

C8H16O2

IUPAC Name:

2-methylpropyl 2-methylpropanoate

Specific details on test material used for the study:

The test substance is identified as Isobutyl isobutyrate. The purity is 98.99%. The physical state/appearance of material is clear colourless liquidwhite solid. The expiry date of material is 6 February 2018. The substance can be stored at room temperature in the dark conditions.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Female Wistar (RccHanTM :WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK.The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed of the mean body weight at the start of treatment.
The temperature and relative humidity were set to achieve limits of 19 to 25 o c and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg

No. of animals per sex per dose:

A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.

Details on study design:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals. Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: There were no cllinical observations.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Globally Harmonized Classification System — Unclassified

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System — Unclassified).

Executive summary:

The study was performed to assess the acute oral toxicity of the Isobutyl isobutyrate in the Wistar strain rat.

In the absence of toxicity at a dose level of 2000 mg/kg in one animals, an additional group of animals was treated with 2000 mg/kg dose level. A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths observed during the test. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System — Unclassified).