Pentane-2,4-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-01-09 to 1985-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conduction and documentation of study very acceptable. Study report available.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

publication

Title:

The acute toxicity and primary irritancy of 2,4-pentanedione

Author:

Ballantyne, B., Dodd, D.E., Myers R.C., Nachreiner, D.J.

Year:

1986

Bibliographic source:

Drug and Chemical Toxicology, 9, 133-146

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as stated in report

Deviations:

no

Principles of method if other than guideline:

Method: other
5 male or 5 female Hilltop-Wistar rats (weight 200 - 300g) per group; 4 doses tested; 14 d postdosing observation period; undiluted TS was given by means of stomach intubation with a ball-end stainless steel needle.

GLP compliance:

yes

Test type:

other:

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentane-2,4-dione

EC Number:

204-634-0

EC Name:

Pentane-2,4-dione

Cas Number:

123-54-6

Molecular formula:

C5H8O2

IUPAC Name:

pentane-2,4-dione

Details on test material:

- Name of test material (as cited in study report): 2,4-Pentanedione
- Substance type: industrial chemical
- Physical state: liquid
- Analytical purity: > 99%
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 496500
- Expiration date of the lot/batch: not given
- Stability under test conditions: stable
- Storage condition of test material: not given

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not given
- Humidity (%): not given
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not used

MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg bw

Doses:

1, 0.71, 0.50, 0.25 ml/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: observations daily, weighting at days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50s are calculated using the method of Thompson moving average method.

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

760 mg/kg bw

95% CL:

655 - 890

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

570 mg/kg bw

95% CL:

485 - 675

Mortality:

LD50 in male and female rats 760 and 570 mg/kg, respectively; most deaths occurred within 5 hours after administration

Clinical signs:

other: signs of toxicity included sluggishness, tremors, kyphosis, lacrimation, unsteady gait, comatose appearance and prostration. Survivors recovered at one to two days.

Gross pathology:

At necropsy, findings included few remarkable lesions except enlarged cervical lymph nodes in most animals, suggesting the presence of a minor infection.

Other findings:

not reported

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Substance is harmful to rats following oral exposure.

Executive summary:

Acetylacetone (2,4 -Pentanedione) was administered to groups of 5 male and 5 female Hilltop-Wistar rats via peroral intubation. The rats received the test material (1, 0.71, 0.5 and 0.25 ml/kg bw respectively) by stomach intubation with a ball-endstainless steel needle. The sample was injected by means of a syringe and doses are varied by adjusting the volume of the test materials. The rats were fastened overnightbefore dosing.

The LD50 for male rats receiving 2,4 -Pentanedione were 760 mg/kg bw for males and 570 mg/kg bw for females. Sluggishness , tremors, kyphosis, lacrimation, unsteady gait, comatose appearance and prostration among the signs of toxicity noted. Most deaths occured within 5 hours. Survivors recovede at one to two days.

At necropsy findings included few remarkable lesions except enlarged cervial lymph nodes in most animals. This mostly slight condition suggested the presence of a minor infection. There were no clinical signs of such an infection and this condition was not believed to have affected the results of the test.