1,2,3-Propanetriol, mono- and diformates

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Low number of experimental animals per dose group, only one dose level has bee tested, and not all examination parameters of an OECD 414 study were fulfilled.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1995

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

not specified

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium formate

EC Number:

205-488-0

EC Name:

Sodium formate

Cas Number:

141-53-7

IUPAC Name:

sodium formate

Test material form:

not specified

Test animals

Species:

mouse

Strain:

CD-1

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Duration of treatment / exposure:

mice were given a single dose of sodium formate on day 8 of gestation

Frequency of treatment:

once

Duration of test:

dams were sacraficed on day 10 or 18 of gestation

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 750 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

n=10-14

Control animals:

yes

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

750 mg/kg bw (total dose)

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The incidence of neural tube defects was not affected by sodium formate up do a dose of 750 mg/kg bw on day 8 of gestation in CD-1 mice

Executive summary:

In a developmental toxicity study sodium formate was administered to 10-14 female CD-1 mice by oral gavage at dose levels of 0 or 750 mg/kg bw on day 8 of gestation.

The incidence of neural tube defects was not affected by sodium formate. The developmental NOAEL is 750 mg/kg bw, the highest dose administered.  

The developmental toxicity study in the mouse is classified as acceptable, and satisfies the main guideline requirement for a developmental toxicity study (OPPTS 870.3700; OECD 414) in rodents.  Major deficiencies include a low number of experimental animals per dose group, testing only one dose level, and not all examination parameters were fulfilled.