Syrups, wheat, hydrolyzed starch

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:

weight of evidence

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation for a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

- lack of details on test article (missing important information on purity, stability, & homogeneity) & information on verification of test concentrations.

GLP compliance:

no

Remarks:

- study predates GLP

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

D-glucitol

EC Number:

200-061-5

EC Name:

D-glucitol

Cas Number:

50-70-4

IUPAC Name:

D-glucitol

Details on test material:

- Name of test material (as cited in study report): FDA 71-31 (Sorbitol)
- Physical state: White crystals

Test animals

Species:

mouse

Strain:

CD-1

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: 28.2 to 30.6 g
- Fasting period before study: Not reported
- Housing: Individually Housed in disposable plastic cages in temperature and humidity-controlled quarters
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: Not reported

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

Not reported

Details on mating procedure:

- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: Not reported
- Length of cohabitation: Not reported
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy

Duration of treatment / exposure:

Test article administration = Day 6 to Day 15. Animals were killed on Day 17.

Frequency of treatment:

Once/day from Days 6 to 15.

Duration of test:

Approximately 20 days.

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 16, 74, 350, or 1600 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

Between 19 and 21 pregnant females/dose.

Control animals:

yes, sham-exposed

Details on study design:

- Dose selection rationale: Not reported

Examinations

Maternal examinations:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: on Days 0, 6, 11, 15, and 17 of gestation

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 17
- Organs examined: Uterus (more organs not reported)

Ovaries and uterine content:

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

Fetal examinations:

- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one-third per litter
- Skeletal examinations: Yes: two-thirds per litter
- Head examinations: No

Statistics:

Statistics performed; however, statistical tests were not reported.

Indices:

Not reported

Historical control data:

Not reported

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Basis for effect level:

other: maternal toxicity

Remarks on result:

not determinable

Remarks:

no NOAEL identified

2

Dose descriptor:

NOAEL

Basis for effect level:

other: developmental toxicity

Remarks on result:

not determinable

Remarks:

no NOAEL identified

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

Executive summary:

NOAEL values were not reported by the study authors.  Review of the study data suggests that a NOAEL of 1600 mg/kg bw (the highest level administered) can be considered for both maternal and fetal toxicity based on a lack of toxicity.