Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June, 28, 1984 to December 11, 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol, propoxylated, esters with acrylic acid
EC Number:
500-114-5
EC Name:
Glycerol, propoxylated, esters with acrylic acid
Cas Number:
52408-84-1
Molecular formula:
(C3H6O)m(C3H6O)n(C3H6O)oC12H14O6
IUPAC Name:
Poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.',.alpha.''-1,2,3- propanetriyltris[.omega.-[(1-oxo-2-propenyl)oxy]]-

Test animals

Species:
rat
Strain:
other: Sprague Dawley COBS CD rats
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding laboratories, Inc., Portage, Michigan
- Age at study initiation: 13 wk
- Weight at study initiation: 225- 297 g (on Day 0 of gestation)
- Housing: Individually housed in wire mesh cages suspended above cage board
- Diet: Purina certified rodent chow; ad libitum
- Water: Tap water; ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 0.16 °C
- Humidity( % ): 40 %
- Photoperiod(h dark / h light): 12 h dark / 12 h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
A specified amount of the test material was weighed (not adjusted for purity), and transferred to a volumetric flask: which was first coated with the corn oil vehicle, using a series of vehicle rinses. Vehicle was then added in sufficient quantity to achieve the appropriate concentration. The flasks were inverted and manually shaken several times prior to stirring. The mixtures were stirred continuously for 5 minutes until homogenous using a magnetic stir plate and bars. The mixtures were prepared fresh daily and stirred prior to dispensing. A magnetic stir plate and bars were also utilized during dose administration to ensure adequate mixture. A total volume of 100 mL was prepared daily during the course of the study.

VEHICLE: CORN OIL
- Lot/batch no.: May 14 85
- Purity: 100 %
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- Impregnation procedure: Cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Verification of same strain and source of both sexes: Yes
- Proof of pregnancy: Presence of vaginal plug referred to as Day 0 of pregnancy
Duration of treatment / exposure:
10 d, from Day 6 to 15 of gestation, inclusive
Frequency of treatment:
Once daily
Duration of test:
25 d
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
30 females/dose
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: Based on the results of a range-finding study, the test dosage (1,000 mg/kg bw/day) was selected since it was anticipated to induce some degree of maternal toxicity but one which would not likely affect maternal survival.
- 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, 16 and 20.
- Mean body weight changes were calculated for each corresponding interval of gestation additionally for Day 6-16, 16-20 and 0-20.

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:
- 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: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: all per litter
Statistics:
1. The fetal sex ratios were compared by the Chi-square test with Yates' correction factor.
2. The number of litters with malformations and developmental variations were compared by Fisher's Exact Test
3. The numbers of early and late resorptions, dead fetuses and postimplantation losses were compared by the Mann-Whitney U-test
4. Mean numbers of corpora lutea, total implantations, viable fetuses, mean fetal and maternal body weights and maternal body weight gain at each interval were analyzed by a one-way ANOVA and Dunnett's test
Indices:
- Fetal sex ratios, number of litters with malformations and developmental variations, numbers of early and late resorptions, dead fetuses and postimplantation losses
- Numbers of corpora lutea, total implantations and viable fetuses
Historical control data:
Yes, WlL historical control data appended in the report

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
salivation prior to and following dosing, urogenital matting and hair loss from various body surfaces
Mortality:
no mortality observed
Description (incidence):
Survival was 100% in the control and test item groups.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Significant decrease in mean body weight gain was noticed during gestation Day 6-16.
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no gross internal morphological changes among the dams at the terminal sacrifice which could be considered treatment-induced. Sporadic findings such as renal infarct, white foci in the renal cortex or thickened gastic mucosa were observed in the test material groups and are not uncommon for rats of this strain and age.
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Description (incidence and severity):
There were no biologically meaningful or statistically significant differences concerning the mean numbers of viable fetuses.
Changes in pregnancy duration:
not specified
Changes in number of pregnant:
no effects observed

Effect levels (maternal animals)

Key result
Dose descriptor:
LOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
body weight and weight gain

Maternal abnormalities

Key result
Abnormalities:
no effects observed

Results (fetuses)

Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
not examined
External malformations:
effects observed, non-treatment-related
Description (incidence and severity):
All malformations observed are known to occur spontaneously in this strain of rat.
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
All malformations observed are known to occur spontaneously in this strain of rat. A significant decrease occurred in the number of litters with fetuses having the 5th and 6th sternebrae unossified. This decrease is not considered biologically meaningful and is attributed to random occurrence.
Visceral malformations:
effects observed, non-treatment-related
Description (incidence and severity):
All malformations observed are known to occur spontaneously in this strain of rat

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: no teratogenic or embryotoxic effects

Fetal abnormalities

Key result
Abnormalities:
no effects observed

Overall developmental toxicity

Key result
Developmental effects observed:
no

Applicant's summary and conclusion