Itaconic acid

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

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:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD gideline 415:one- or two- (or multi-) generation studies

GLP compliance:

yes

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:

CD-1

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Duration of treatment / exposure:

day 6 to day 15 of gestation inclusive.

Frequency of treatment:

every day

Duration of test:

day 6 to day 20

Doses / concentrations

Remarks:

Doses / Concentrations:

Basis:
nominal in diet

No. of animals per sex per dose:

22

Control animals:

yes, concurrent no treatment

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day

Basis for effect level:

other: fetotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Maternal and Parental general toxicity : Post-dosing salivation was observed at high doses. There was increase of brown staining of one or more regions of the body at 500 and 1000 mg/kg/d. Bodyweight gain during treatment was unaffected. Food intake during gestation was similar for all groups. Water intake was increased during treatment and up to termination at 1000 mg/kg/d when compared to the controls. Pregnancy and litter data : All the females were pregnant and no death occurred. Litter responses as indicated by the survival, growth and development of foetuses in utero revealed no treatment-related effects Foetal data (live/dead, sex, external defects, soft tissue and skeletal defects) : Foetal examination at necropsy, and following free hand serial sectioning or skeletal examination did not revealed any treatment related findings.