Bis(pentane-2,4-dionato-O,O')magnesium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(pentane-2,4-dionato-O,O')magnesium

EC Number:

237-857-7

EC Name:

Bis(pentane-2,4-dionato-O,O')magnesium

Cas Number:

14024-56-7

Molecular formula:

C10H14MgO4

IUPAC Name:

magnesium;4-oxopent-2-en-2-olate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Physical state / Appearance:
white powder
Storage Conditions:
room temperature in the dark

For the purpose of the study the test item was freshly prepared, as required, as a suspension in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

On receipt the animals were randomly allocated to cages. 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 ±20% of the mean body weight at the start of treatment.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

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:

In the absence of data on the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
A single animal was treated as follows: 300mg/kg
In the absence of mortality or evident toxicity at a dose level of 300 mg/kg, an additional animal was treated as follows: 2000mg/kg
Due to mortality at a dose level of 2000 mg/kg, an additional group of 4 animals was treated as follows: 300mg/kg

No. of animals per sex per dose:

4 females were dosed at 300mg/kg
1 female was dosed at 2000mg/kg

Control animals:

no

Details on study design:

Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 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 or at death.
At the end of the observation period the surviving 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

Preliminary study:

n the absence of data on the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
A single animal was treated as follows: 300mg/kg
In the absence of mortality or evident toxicity at a dose level of 300 mg/kg, an additional animal was treated as follows: 2000mg/kg

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

<= 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

Mortality:

Dose Level - 300 mg/kg: There were no deaths.
Dose Level - 2000 mg/kg: The animal treated at a dose level of 2000 mg/kg was killed for humane reasons one hour after dosing, due to the occurrence of clinical signs of toxicity that approached the severity limit set forth in the UK Home Office Project License.

Clinical signs:

other: Dose Level - 300 mg/kg: No signs of systemic toxicity were noted during the observation period. Dose Level - 2000 mg/kg: Signs of systemic toxicity noted were hunched posture, pilo-erection, labored respiration, decreased respiratory rate, pallor of the e

Gross pathology:

Dose Level - 300 mg/kg: No abnormalities were noted at necropsy.
Dose Level - 2000 mg/kg: Abnormalities noted at necropsy were white liquid in the stomach and a thickened gastric mucosa.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight;