1,3-Propanediol, 2,2-bis(hydroxymethyl)-, polymer with 2-(chloromethyl)oxirane, 2-propenoate

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:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Study is equivalent or similar to OECD Guideline 414, but only a single dose was tested, which did not cause maternal toxicity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3525-68-3

IUPAC Name:

3525-68-3

Details on test material:

- Name of test material (as cited in study report): C-253
- Physical state: amber, crystalline solid
- Analytical purity: 100 %
- Lot/batch No.: 3-81

Test animals

Species:

rat

Strain:

other: CRL:COBS CD (SD)BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Inc. Kingston New York
- Age at study initiation: 12-14 and 8-10 weeks
- Housing: individually
- Diet (e.g. ad libitum): Purina rodent Laboratory Chow, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature: 74 °F (S.D. = 0.4)
- Humidity (%): 40 (S.D. = 8.0)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: Test material was heated in a water bath to liquified, corn oil was assed and stirred into solution.

Details on mating procedure:

1 male per 2 females were placed in breeding cage for max. of 2 weeks.
Maiting confirmd by the presecne of a vaginal plug or by examination of vaginal smears for the presence of sperm.
The day mating was confirmed was designated as day 0 for each female.

Duration of treatment / exposure:

10 days, from Days 6 through 15 of gestation

Frequency of treatment:

once daily

Duration of test:

28 days

Doses / concentrations

Remarks:

Doses / Concentrations:
10 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

15 male and 29 female rats
25 female rats for the treatment group

Details on study design:

- Dose selection rationale: Based on the results of a range-finding study
- Rationale for animal assignment: Random

Examinations

Maternal examinations:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: from day 0 through 20 of gestation

BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 6, 9, 12, 15 and 20 of gestation

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- 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: [two-thirds per litter ]
- Skeletal examinations: Yes: [ two-thirds per litter ]

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Details on maternal toxic effects:
- one femalt died on Day 15 of gestation, no abnormals findings were noted at necropsy, death may be attributet to treatment.
- clinical obxervations were alopecia and wheezing
- Body weights and weight changes were within normal limits
- Food an water consumption were within normal limits.
- pregnancy rate, the mean numbers of corpora lutea and implantations, and the mean implantation efficiency were within normal limits.
- Mean gravid and nongravid uterine weights were within normal limits.

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Details on embryotoxic / teratogenic effects:
No test substance related adverse effects were observed on fetal viability, weights, sex or during visceral or sceletal examinations.

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

10 mg/kg bw/day

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified