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EC number: 278-717-5 | CAS number: 77538-19-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
- Reference Type:
- publication
- Title:
- Teratologic Evaluation of Glycerine
- Author:
- NTIS US Department of Commerce
- Year:
- 1 974
- Bibliographic source:
- PB-234 876
Materials and methods
- Principles of method if other than guideline:
- Pre-natal developmental toxicity study in rats exposed on Days 6-15 of gestation by oral gavage. Examinations of uterine content included: No. of implantation sites, resorptions and live and dead fetuses. Examination of fetuses included: body weight, sex, external abnormalities, visceral (1/3 of fetuses) and skeletal (2/3 of fetuses) examinations.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-89 (Glycerol; glycerine)
- Physical state: water-white syrupy liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 214-230 g (on Day 0 of gestation)
- Housing: Animals were individually housed in mesh bottom cages.
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified, reported as controlled.
- Humidity (%): Not specified, reported as controlled.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test material was prepared and doses calculated according to Table 1.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: presumably 1/1
- Proof of pregnancy: vaginal plug referred to as Day 0 of pregnancy - Duration of treatment / exposure:
- 10 days (Day 6-15 of gestation)
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
13.1, 60.8, 282 and 1310 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Negative control: 25
Positive control: 29
13.1 mg/kg bw/day: 25
60.8 mg/kg bw/day: 28
282 mg/kg bw/day: 25
1310 mg/kg bw/day: 25 - Control animals:
- yes, concurrent vehicle
- other: positive control: Aspirin (250 mg/kg bw/day)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations included: appearance and behaviour with particular attention to food consumption and weight
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 11, 15 and 20 of gestation
FOOD CONSUMPTION: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day 20
- Organs examined: urogenital tract - Ovaries and uterine content:
- The uterine content was examined after termination: Yes
Examinations included:
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of live and dead fetuses: Yes - Fetal examinations:
- - Body weight: Yes: all live pups per litter
- Sex ratio: Yes: all live pups per litter
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one third per litter
- Skeletal examinations: Yes: two thirds per litter
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
MORTALITY
No mortality occurred.
BODY WEIGHT
No treatment-related effects observed.
FOOD CONSUMPTION
Not reported.
CLINICAL SIGNS
Not reported.
PREGNANCIES AND LIVE LITTERS (No. of pregnant animals or live litters/No. total mated animals)
No treatment-related effects observed.
Negative control: 23/25
Positive control: 24/29
13.1 mg/kg bw/day: 24/25
60.8 mg/kg bw/day: 22/28
282 mg/kg bw/day: 22/25
1310 mg/kg bw/day: 21/25
ABORTIONS
There were no abortions.
IMPLANTATIONS (mean value per dam)
No treatment-related effects observed.
Negative control: 11.4
Positive control: 10.9
13.1 mg/kg bw/day: 11.0
60.8 mg/kg bw/day: 12.4
282 mg/kg bw/day: 12.0
1310 mg/kg bw/day: 11.2
RESORPTIONS (Total No. of resorptions/No. of dams involved/No. of dams examined)
No treatment-related effects observed.
Negative control: 2/2/23
Positive control: 40/11/24
13.1 mg/kg bw/day: 4/1/24
60.8 mg/kg bw/day: 1/1/22
282 mg/kg bw/day: 4/2/22
1310 mg/kg bw/day: 3/2/21
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 310 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
MORTALITY
There were no dead fetuses in the negative control and treatment groups.
In the positive control group, 3 dams showed 1 dead fetus each.
BODY WEIGHT (Mean fetus body weight in g)
No treatment-related effects observed.
Negative control: 3.80
Positive control: 2.37
13.1 mg/kg bw/day: 3.76
60.8 mg/kg bw/day: 3.89
282 mg/kg bw/day: 3.86
1310 mg/kg bw/day: 3.83
LIVE FETUSES
No treatment-related effects on number of viable fetuses and sex ratio.
- Mean No. of viable fetuses per dam:
Negative control: 11.0
Positive control: 9.08
13.1 mg/kg bw/day: 10.8
60.8 mg/kg bw/day: 12.3
282 mg/kg bw/day: 11.8
1310 mg/kg bw/day: 11.1
- Sex ratio (m/f):
Negative control: 0.77
Positive control: 1.06
13.1 mg/kg bw/day: 0.90
60.8 mg/kg bw/day: 0.94
282 mg/kg bw/day: 1.02
1310 mg/kg bw/day: 0.83
EXTERNAL EXAMINATIONS
No external abnormalities reported.
SOFT TISSUE EXAMINATIONS
No soft tissue abnormalities were observed in the negative control and treatment groups.
In the positive control group, 15 out 24 litters showed 1-3 pups with visceral abnormalities each. Abnormalities included: meningoencephalocele, anopia, cleft palate, harelip, encephalomyelocele, gastroschisis, umbilical hernia and hydrocephalus.
SKELETAL EXAMINATIONS
Delayed ossification was observed in all control and treatment groups without evidence for a relationship to treatment (Table 2).
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 310 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 2. Summary of skeletal findings (No. fetuses affected/No. of litters affected)
Findings |
Dose level (mg/kg bw/day) |
|||||
|
Negative control |
Positive control |
13.1 |
60.8 |
282 |
1310 |
Live fetuses examined |
183/23 |
157/24 |
180/24 |
189/22 |
182/22 |
163/21 |
Sternebrae |
||||||
Incomplete ossification |
54/16 |
78/21 |
52/17 |
37/14 |
35/11 |
47/15 |
Bipartite |
- |
21/15 |
- |
2/2 |
- |
- |
Fused |
- |
1/1 |
- |
- |
- |
- |
Missing |
11/6 |
131/23 |
15/7 |
9/6 |
6/4 |
2/2 |
Ribs |
||||||
Incomplete ossification |
1/1 |
9/5 |
- |
- |
- |
1/1 |
Fused/split |
- |
13/7 |
- |
- |
- |
- |
Wavy |
26/10 |
46/17 |
25/12 |
5/5 |
11/8 |
9/6 |
Less than 12 |
- |
3/2 |
- |
- |
- |
|
More than 13 |
- |
126/24 |
1/1 |
- |
- |
3/1 |
Vertebrae |
||||||
Incomplete ossification |
45/14 |
115/23 |
15/9 |
14/9 |
12/5 |
10/5 |
Skull |
||||||
Incomplete closure |
34/11 |
71/19 |
22/9 |
26/15 |
18/9 |
35/13 |
Missing |
- |
7/5 |
- |
- |
- |
- |
Extremities |
||||||
Incomplete ossification |
- |
2/2 |
- |
- |
- |
- |
Miscellaneous |
||||||
Hyoid; reduced |
36/13 |
77/21 |
10/8 |
23/11 |
17/10 |
19/10 |
Hyoid; reduced |
25/10 |
9/7 |
14/9 |
11/8 |
26/9 |
14/7 |
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