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EC number: 946-420-6 | CAS number: -
- 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
- Nanomaterial catalytic activity
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- A three-generation reproduction study on polyglycerol polyricinoleate (PGPR) in Wistar rats.
- Author:
- Wilson R, Smith M.
- Year:
- 1 998
- Bibliographic source:
- Food Chem Toxicol. 1998 Sep-Oct;36(9-10):739-41.
Materials and methods
- Principles of method if other than guideline:
- A continuous breeding protocol was adopted, in which the breeding pairs were maintained until the female had produced five litters or when it became evident that breeding had ceased. The main focus of the study design was to observe any effect on breeding. The parameters measured in each of the three generations included number of litters per dam, average litter size, average weaning weights of males and females, litters per group showing 100% survival and total survival (%) at day 21.
- GLP compliance:
- no
- Remarks:
- study was conducted in the 1950s and 1960s
Test material
- Reference substance name:
- 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)-, polymer with 1,2,3-propanetriol
- Cas Number:
- 29894-35-7
- IUPAC Name:
- 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)-, polymer with 1,2,3-propanetriol
- Test material form:
- liquid
- Details on test material:
- Hydroxyl value 85±100
Acid value 2.0 max.
Iodine value 80±90
Refractive index at 658C 1.4635±1.4665
"the polyglycerol moiety shall be composed of not less than 75 percent of the di-, tri- and tetraglycerols and shall contain not more than 10 percent of polyglycerols equal to or higher than heptaglycerol'' (FAO, 1992).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Unilever Colworth Laboratory, Sharnbrook, Bedford, UK
- Age at study initiation: (P) x wks; (F1) x wks
- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
Fresh mixes were prepared each week, and PGPR was incorporated into the ground diet first by hand, then well mixed in a mechanical mixer.
The dietary level of 1.5% PGPR was chosen to provide an intake by the pregnant and lactating rat which was in excess of 150 times the intake of a person consuming 5 mg PGPR/kg body weight/day. - Frequency of treatment:
- continuously via diet
- Details on study schedule:
- All rats were weaned at 23 days and mated at 121 days.
Doses / concentrations
- Dose / conc.:
- 1.5 other: % in diet
- No. of animals per sex per dose:
- control (11 males and 17 females),
treatment group (six males and 13 females) - Control animals:
- yes, plain diet
Examinations
- Statistics:
- A Student's t-test was conducted in which the two groups were compared.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in clinical signs in treated or control rats which indicated an effect of treatment with PGPR. There was no evidence of abnormal behaviour or functional disorder associated
with the consumption of PGPR throughout the three generations of the study. - Mortality:
- no mortality observed
- Description (incidence):
- There were no deaths during the experimental period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weight data for test and control rats indicate that they both grew in a similar, normal pattern.
- Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- Food intakes were not recorded in this study, but it has been previously shown that levels of 5% PGPR in the diet has no effect on food intake
- 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
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
In the second generation, breeding performance was poor for both diets with the only significant difference being that control rats had a significantly greater percentage of litters weaned entirely, which was reversed in favour of the PGPR rats in the third generation. One further difference in the second generation was the higher proportion of males among the weaned rats fed PGPR. As rats were not sexed until weaning, it is not known if this is due to a higher proportion of males being born, or to the males surviving better than the females.
The developmental period from birth to weaning is considered extremely critical. In generations 1 and 3 a high percentage of the offspring were weaned for both groups. However, in the second generation there was a reduction in the percentage of animals weaned. As this reduction occurred in both groups and to a similar extent it is concluded that this was due to an unknown environmental factor.
In conclusion, the similarity observed between the data obtained for the first and third generations failed to provide any evidence of a cumulative effect due to long-term ingestion of PGPR over three successive generations.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Table 1. Breeding performance
|
1st generation |
2nd generation |
3rd generation |
|||
Reproductive parameter |
Control |
PGPR |
Control |
PGPR |
Control |
PGPR |
No. of females |
17 |
13 |
52 |
32 |
92 |
44 |
Females failing to breed (%) |
0 |
0 |
15 |
16 |
17 |
16 |
Litters born (average/female) |
4.7 |
4.6 |
4.4 |
3.2 |
3.5 |
4.0 |
Females producing five litters (%) |
76 |
85 |
50 |
41 |
52 |
70 |
Average size of litters |
8.4 |
7.4 |
7.2 |
7.2 |
7.0 |
7.4 |
Rats weaned/rats born (%) |
79 |
79 |
54 |
44 |
70 |
83 |
Litters entirely weaned (%) |
57 |
64 |
38 |
22 |
53 |
67 |
Average weight of weanling males (g) |
37.8 |
37.3 |
33.7 |
33.7 |
36.8 |
35.4 |
Average weight of weanling females (g) |
36.1 |
36.2 |
32.5 |
30.8 |
36.4 |
33.6 |
Weanling males/all weanling (%) |
48 |
48 |
48 |
57 |
46 |
50 |
Table 2. Growth of rats from weaning to mating (females) or 65 days (males)
|
|
Females |
|
|
Males |
|
|
Group |
Generation |
No. of females |
Average weight at weaning [g] |
Average weight gain at mating [g] |
No. of males |
Average weight at weaning [g] |
Average weight gain 65 d [g] |
Control |
1 |
17 |
40 |
131 |
11 |
43 |
155 |
|
2 |
42 |
38a |
134a |
52 |
39 |
150 |
|
3 |
92 |
35 |
130 |
92 |
35 |
126 |
PGPR |
1 |
13 |
38 |
127 |
6 |
40 |
143 |
|
2 |
32 |
37 |
127 |
32 |
39 |
143 |
|
3 |
44 |
33 |
119 |
44 |
35 |
112 |
a) Average of 50 animals.
*Indicates that the value is significantly greater (P = 0.05) than the other group in the same generation.
Table 3. Proportion of rats born and weaned
Treatment |
Generation |
No. of breeding females |
Rats born |
Rats weaned |
% Weaned |
Control |
1 |
17 |
664 |
526 |
79.0 |
PGPR |
|
13 |
447 |
353 |
78.9 |
Control |
2 |
52 |
1312 |
710 |
54.0 |
PGPR |
|
32 |
749 |
334 |
44.0 |
Control |
3 |
92 |
2263 |
1595 |
70.0 |
PGPR |
|
44 |
1325 |
1098 |
82.8 |
Applicant's summary and conclusion
- Conclusions:
- In the period of most rapid growth for the rats, polyglycerol polyricinoleate had no effect on the food intake during this period and had no subsequent effect on the growth of the rats.
During the three-generation study the breeding females consumed polyglycerol polyricinoleate at levels of greater than 2 g/kg body weight (based on a food intake level of up to 40 g/day during lactation and the inclusion of polyglycerol polyricinoleate in the diet at the fixed level of 1.5%). At this level of polyglycerol polyricinoleate consumption the breeding performance of the treated rats was similar to those rats fed the control diet. There was no effect of polyglycerol polyricinoleate on the suckling pups receiving polyglycerol polyricinoleate from their mothers' milk.
The ingestion of polyglycerol polyricinoleate at a dietary level of 1.5% did not produce any adverse effect on reproductive capacity or development of the offspring during three generations of continuous exposure.
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