D-gluconic acid

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: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

Purity, source of test substance, analytical verification, statistical methods, temperature, humidity, age, acclimation, environmental conditions, not reported

GLP compliance:

no

Remarks:

Study pre-dates GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

D-glucono-1,5-lactone

EC Number:

202-016-5

EC Name:

D-glucono-1,5-lactone

Cas Number:

90-80-2

IUPAC Name:

3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-one (non-preferred name)

Details on test material:

- Name of test material (as cited in study report): Glucono Delta Lactone

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Average weight on day 0 = 217.83 g
- Fasting period before study: Not reported
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature and humidity was controlled but numbers not reported
- Humidity (%): temperature and humidity was controlled but numbers not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light):Not reported


IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:
Test material was prepared and doses calculated according to the following table:

Dosage (mg/kg) Dose(ml/kg Concentration (mg/ml)
<250 1 <250
251-500 2 125-250
501-750 3 133-250
751-1000 4 187-250
1001-1250 5 200-250
1251-1500 6 208-250
1501-1600 6.4 235-250

- No further details on preparation of dosing solutions

VEHICLE
- Amount of vehicle (if gavage): Not reported
- Lot/batch no. (if required): Not reported
- Purity:Not reported

Analytical verification of doses or concentrations:

no

Details on mating procedure:

- Impregnation procedure: mated with young adult males, no further details
- If cohoused: Not reported
- M/F ratio per cage: Not reported
- Length of cohabitation: Not reported
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. Not reported
- Further matings after two unsuccessful attempts: Not reported
- Verification of same strain and source of both sexes: Not reported
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy
- Any other deviations from standard protocol: Not reported

Duration of treatment / exposure:

Day 6 to day 15 of gestation

Frequency of treatment:

Daily

Duration of test:

17 days (mating to death)

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
5.94 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 3

Remarks:

Doses / Concentrations:
27.6 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 4

Remarks:

Doses / Concentrations:
128.0 mg/kg bw/day
Basis:
actual ingested

Doses / concentrations 5

Remarks:

Doses / Concentrations:
594.0 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose:

21 to 24 pregnant females per group

Control animals:

yes, concurrent vehicle

Details on study design:

- Dose selection rationale: according to table included in report however no further rationale or reference for table
- Rationale for animal assignment (if not random): random

Examinations

Maternal examinations:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table included: No


DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: End of treatment


BODY WEIGHT: Yes
- Time schedule for examinations:days 0, 6, 11, 15, and 20 of gestation


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Not applicable - Oral gavage study


WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not applicable - Oral gavage study


POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: reproductive organs

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of early resorptions: No
- Number of late resorptions: No

Fetal examinations:

- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 per litter
- Skeletal examinations: Yes: 2/3 per litter
- Head examinations: Yes: 2/3 per litter

Statistics:

No data

Indices:

No data

Historical control data:

No data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
None

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

594 mg/kg bw/day (actual dose received)

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the controls.

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified