Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion