Pentane-2,4-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1986

Reference 3

Reference Type:

secondary source

Title:

Unnamed

Year:

2001

Materials and methods

Principles of method if other than guideline:

Five male and five female Hilltop-Wistar rats (weight 200- 300 g) per group; 4 doses tested (0.25, 0.50, 0.71 and 1.00 mL/kg bw; equivalent to 243, 485, 689 and 970 mg/kg bw, respectively); 14 d postdosing observation period; undiluted 2,4-pentanedione was given by means of stomach intubation with a ball-end stainless steel needle .

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

Purity: >99%
Physical state: yellow, transparent non-viscous liquid
Lot No.: 496-500

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
1 mL/kg bw

Doses:

243, 485, 689 and 970 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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

760 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

570 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

0.78 mL/kg bw

Based on:

test mat.

95% CL:

>= 0.66 - <= 0.91

Remarks on result:

other: 0.78 mL/kg bw corresponds to 757 mg/kg bw

Effect levels 4

Sex:

female

Dose descriptor:

LD50

Effect level:

0.59 mL/kg bw

Based on:

test mat.

95% CL:

>= 0.51 - <= 0.7

Remarks on result:

other: 0.59 mL7kg bw corresponds to 573 mg/kg bw

Mortality:

5/5 males and 5/5 females died in the 1.00 mL/kg dose group and 1/5 males and 5/5 females in the 0.71 mL/kg dose group. No mortality occurred in the low dose groups. Most deaths occurred within 5 hours after administration.

Clinical signs:

other: Signs of toxicity at 0.50 mL/kg and higher doses included sluggishness, tremors, kyphosis, lacrimation, unsteady gait, comatose appearance and prostration.

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of the study, an LD50 of 570-760 mg/kg bw was derived warranting classification according to GHS and CLP (EC) No. 1272/2008 in category 4.