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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
760 mg/kg bw
95% CL:
655 - 890
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:
signs of toxicity included sluggishness, tremors, kyphosis, lacrimation, unsteady gait, comatose appearance and prostration. Survivors recovered at one to two days.
Body weight:
not reported
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.