Dibismuth trisulphide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study published only as an abstract therefore it is not possible to fully assess reliability.

Data source

Reference

Reference Type:

publication

Title:

Effects of bismuth citrate on pregnant rats and rabbits.

Author:

Secker, RC

Year:

1993

Bibliographic source:

Teratology 1993 Aug;48(2):33A

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Study published as an abstract only - no information is provided regarding whether any guideline was followed, but the data suggest a similar design as described in OECD 414.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bismuth citrate

EC Number:

212-390-1

EC Name:

Bismuth citrate

Cas Number:

813-93-4

IUPAC Name:

bismuth(3+) citrate

Test animals

Species:

rabbit

Strain:

other: dutch rabbits

Details on test animals or test system and environmental conditions:

- female Dutch rabbits

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous aluminium hydroxide

Duration of treatment / exposure:

Female rabbits: Days 8-20 of pregnancy inclusive (day of mating is Day 1 of pregnancy).

Frequency of treatment:

Once daily

Duration of test:

Approximately 23 days

Doses / concentrations

Remarks:

Doses / Concentrations:
50, 100 or 200 mg/kg bw
Basis:

Details on study design:

On Day 30 the rabbits were subjected to autopsy and foetuses examined for external, visceral and skeletal abnormalities.

Examinations

Fetal examinations:

Rabbit foetuses were examined for external, visceral and skeletal abnormalities.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:yes

Details on maternal toxic effects:
Marked reduction in maternal body weight occurred in rabbits. No information regarding dose at which toxic effects occurred.

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
It was concluded that no adverse effects upon pre- or post-implantation loss, numbers of viable foetuses or foetal development were apparent.

Effect levels (fetuses)

1

Dose descriptor:

NOEL

Effect level:

200 mg/kg bw/day (nominal)

Based on:

no data

Basis for effect level:

other: teratogenicity

2

Dose descriptor:

NOEL

Effect level:

200 mg/kg bw/day (nominal)

Based on:

no data

Basis for effect level:

other: embryotoxicity

3

Dose descriptor:

NOEL

Effect level:

200 mg/kg bw/day (nominal)

Based on:

no data

Basis for effect level:

other: fetotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

It was concluded that no adverse effects of the test substance bismuth citrate upon pre- or post-implantation loss, numbers of viable foetuses or foetal development were apparent, even tested at systemic toxic doses.

Executive summary:

In this study (Secker, 1993), which has been published as an abstract only, the test substance bismuth citrate was administered to female Dutch rabbits. On Day 30 (day of mating is Day 1 of pregnancy) the rabbits were subjected to autopsy and foetuses examined for external, visceral and skeletal abnormalities. Plasma bismuth levels were determined at the beginning and end of the treatment period. Plasma levels up to 420 ng/g were recorded. Maternal toxicity, manifest as a marked reduction in body weight, was apparent in the rabbit. Numbers of viable foetuses or foetal development was not affected.