4-O-β-D-galactopyranosyl-D-glucitol

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Remarks:

Article is in Japanese; abstract only in English.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Reproductive and developmental toxicity studies of lactitol (NS-4) (3) — Teratogenicity study in rabbits by oral administration

Author:

Tesh JM, Ross FW, Wightman TJ, Wilby OK, Weith A, Watanabe M, Sumi N.

Year:

1994

Bibliographic source:

J. Tox. Sci., 19(Suppl 3):463-470

Reference 2

Reference Type:

publication

Title:

Reproductive and developmental toxicity studies of lactitol (NS-4) (3) - Teratogenicity study in rabbits by oral administration

Author:

Tesh JM , Ross FW, Wightman TJ, Wilby OK, Weith A, Watanabe M, and Sumi N

Year:

1995

Bibliographic source:

J. Tox. Sci., 20(2):172

Materials and methods

Principles of method if other than guideline:

The test substance was administered by oral gavage to pregnant New Zealand white rabbits during organogenesis from day 6 to day 18 of gestation inclusive, at dosages of 0, 0.25, 0.75, or 4.5 g/kg/day. On day 29 of gestation, females were killed to allow examination of their uterine contents.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-O-β-D-galactopyranosyl-D-glucitol

EC Number:

209-566-5

EC Name:

4-O-β-D-galactopyranosyl-D-glucitol

Cas Number:

585-86-4

Molecular formula:

C12H24O11

IUPAC Name:

4-O-beta-D-galactopyranosyl-D-glucitol

Specific details on test material used for the study:

Test material:
NS-4
CAS 585-86-4

Test animals

Species:

rabbit

Strain:

New Zealand White

Administration / exposure

Route of administration:

oral: gavage

Duration of treatment / exposure:

Days 6 to 18 of gestation

Frequency of treatment:

Daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.25 other: g/kg/day

Doses / concentrations 2

Dose / conc.:

0.75 other: g/kg/day

Doses / concentrations 3

Dose / conc.:

4.5 other: g/kg/day

Control animals:

yes

Details on study design:

On day 29 of gestation, females were killed to allow examination of their uterine contents.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

There was a slight reduction in food intake and faecal output among females receiving 4.5 g/kg. One female receiving 4.5 g/kg aborted following a prolonged period of weight loss.

Effect levels (maternal animals)

Dose descriptor:

NOEL

Effect level:

>= 0.75 other: g/kg

Basis for effect level:

clinical signs

food consumption and compound intake

Results (fetuses)

Details on embryotoxic / teratogenic effects:

No adverse effects on litter parameters were recorded that could be attributed to treatment. Foetal morphogenesis was unaffected by treatment with the test substance.

Effect levels (fetuses)

Dose descriptor:

NOEL

Effect level:

>= 4.5 other: g/kg

Basis for effect level:

other: highest dose tested

Fetal abnormalities

Abnormalities:

no effects observed

Overall developmental toxicity

Developmental effects observed:

no

Applicant's summary and conclusion

Conclusions:

The no-effect level of the test substance is 0.75 g/kg in mother rabbits for general toxicity and for reproductive functions, and 4.5 g/kg for their foetuses.

Executive summary:

Lactitol was administered by oral gavage to pregnant New Zealand white rabbits during organogenesis from day 6 to day 18 of gestation inclusive, at dosages of 0, 0.25, 0.75, or 4.5 g/kg/day. On day 29 of gestation, females were killed to allow examination of their uterine contents. There was a slight reduction in food intake and foetal output among females receiving 4.5 g/kg. One female receiving 4.5 g/kg aborted following a prolonged period of weight loss. No adverse effects on litter parameters were recorded that could be attributed to treatment. Foetal morphogenesis was unaffected by treatment with lactitol. The results show that no-effect dose levels of lactitol are 0.75 g/kg in mother rabbits for general toxicity and for reproductive functions, and 4.5 g/kg for their fetuses.