Itaconic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

EEC 84/449 B1

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Itaconic acid

EC Number:

202-599-6

EC Name:

Itaconic acid

Cas Number:

97-65-4

Molecular formula:

C5H6O4

IUPAC Name:

2-methylidenebutanedioic acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: gum arabic

Doses:

0, 2560, 3100, 3750, 4130, 4550 and 5000 mg/kg bodyweight

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Fasted rats 5 males and 5 females per dose were given a single dose by gavage of itaconic acid, formulated in gum arabic at 0, 2560, 3100, 3750, 4130, 4550 and 5000 mg/kg bodyweight. All surviving animals were sacrificed and examined macroscopically on day 15, the end of the observation period.

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

2 969 mg/kg bw

Clinical signs:

other: Clinical signs were ataxia, pilo erection and ptosis associated to cyanosis.

Any other information on results incl. tables

Clinical signs were ataxia, pilo‑erection and ptosis associated to cyanosis. Low bodyweight gains were recorded for males at doses higher than 2560 mg/kg and females at 4130 and 4550 mg/kg. Congested stomach and coloured lungs were observed in dead animals. No abnormalities were recorded at macroscopic examination at termination of the study.