Didodecyl 3,3'-thiodipropionate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report with restrictions (limited information on test item, animal husbandry and results).

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Reference 2

Reference Type:

secondary source

Title:

Final Report on the Safety Assessment of Dilauryl Thiodipropionate

Author:

Liebert MA

Year:

1992

Bibliographic source:

Journal of the american college of toxicology

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

(limited information on test item and animal husbandry, no data on maternal toxicity/food and water consumption)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl 3,3'-thiodipropionate

EC Number:

204-614-1

EC Name:

Didodecyl 3,3'-thiodipropionate

Cas Number:

123-28-4

Molecular formula:

C30H58O4S

IUPAC Name:

didodecyl 3,3'-sulfanediyldipropanoate

Details on test material:

- Name of test material (as cited in study report): Dilauryl thiodipropionic acid
- Physical state: fine white powdered material

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data, virgin
- Weight at study initiation: average 217 g
- Fasting period before study: no data
- Housing: individually housed in mesh bottom cages
- Diet: ad libitum
- Water (fresh): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, but no further details given
- Humidity (%): controlled, but no further details given
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on exposure:

VEHICLE
- Amount of vehicle (if gavage): 1mL/kg bw

Analytical verification of doses or concentrations:

no

Details on mating procedure:

Females were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.

Duration of treatment / exposure:

Day 6 and continuing daily through Day 15 of gestation

Frequency of treatment:

daily

Duration of test:

During pregnancy until caesarian on day 20.

Doses / concentrations

Remarks:

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

No. of animals per sex per dose:

20 or 21, depending on the group

Control animals:

yes, sham-exposed

Details on study design:

250 mg/kg of aspirin was used as a postive control.
Attention was called to the fact that this is the seventeenth of a series of reports performed for the US FDA. Eventually, a total of at least 42 compounds were planned to be tested in 21 pairs; each pair being run concurrently against one sham-treated control and one positive control group. Because
of the inherent variability of biological data of the type dealt with. Here, the accumulation and pooling of sequential sets of control values would greatly enhance the statistical value of the findings and the ultimate reliability of the test results.

Examinations

Maternal examinations:

Body weights were recorded on Days 0, 6, 11, 15, and 20 of gestation. All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.

Ovaries and uterine content:

On Day 20 all dams were subjected to caesarean section under surgical anesthesia, and the numbers of implantation site and resorption sites were recorded. The urogenital tract of each dam was examined in detail for anatomical normality. The number of live and dead fetuses were recorded.

Fetal examinations:

The body weights of the live pups were recorded.
All foetuses were examined grossly for the presence of extemal congenital abnormalities. One-third of the foetuses of each litter underwent detailed visceral examinations employing 10x magnification. The remaining two-thirds were cleared in potassiiam hydroxide (KOH), stained with alizarin red dye and examined for skeletal defects.

Statistics:

not performed

Historical control data:

Not available at the time of reporting.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
The method part states that clinical signs were assessed, but no further details were given in the results part.
No mortalitiy occured and the body weight development was not affected.

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

1 600 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: other:

Maternal abnormalities

Abnormalities:

not specified

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

>= 1 600 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Highest dose tested. No clearly discernible effect on nidation or on maternal or foetal survival. 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 sham-treated controls.

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Treatment with aspirin at 250 mg/kg bw resulted in an increased number of resorptions, dead foetuses, missing, bipartitie or incompletely ossified sternebrae, incompletely ossified vertebrae and incompletely closed skulls.