L-Ascorbic acid, 2-(dihydrogen phosphate), sodium salt (1:3)

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1973

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

Title:

Unnamed

Year:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

no

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ascorbic acid

EC Number:

200-066-2

EC Name:

Ascorbic acid

Cas Number:

50-81-7

IUPAC Name:

5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)

Details on test material:

L(+)-ascorbic acid; no data on purity of the compound

Test animals

Species:

mouse

Strain:

NMRI

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

days 6 through 15 of gestation
Application Volume: 10 mL/kg

Analytical verification of doses or concentrations:

no

Details on mating procedure:

4 females and one male were caged together for 2 hrs. Mice with vaginal plug were regarded as pregnant.

Duration of treatment / exposure:

days 6 through 15 of gestation

Frequency of treatment:

daily

Duration of test:

until day 18 of gestation

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw/d
Basis:

No. of animals per sex per dose:

21-23 females

Control animals:

yes, concurrent vehicle

Details on study design:

On day 28 of gestation, the fetuses were removed by Cesarean section and examined for malformations of the internal organs and of the skeleton.

Examinations

Maternal examinations:

no examinations

Ovaries and uterine content:

no examinations

Fetal examinations:

Teratogenicity test: On day 18 of gestation (malformations of the internal organs and of the skeleton).

Statistics:

Mean, standard deviation, % analysis

Indices:

no examinations

Historical control data:

Basic control group of 915 animals.

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:

Details on embryotoxic / teratogenic effects:
Teratogenicity test:
The treatment did not produce maternally toxic, fetotoxic, or teratogenic effects. There was no effect on gestation or on maternal body weight gain. The number of abortions and resorptions, the mean number of live fetuses per dam, the mean fetal body weight, and the incidence of runts or malformed fetuses were not affected by treatment with the test substance.

Effect levels (fetuses)

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day

Basis for effect level:

other: embryotoxicity

2

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified