Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAElL(reproduction)>/=2000 mg/kg bw/d (rat, three generation study; RL2, non-GLP), read-across from polyglycerol polyricinoleate and Medium chain triglycerides
Link to relevant study records
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar physicochemical, ecotoxicological and toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: the target and source substances are esterification products of fatty acids of varying chain lengths with glycerol and/or polyglycerol.
• the metabolism pathway leads to comparable products (glycerol and/or polyglycerol and medium or long chain fatty acids).
Therefore, read-across from the existing toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see “Justification for read-across” attached to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
see “Justification for read-across” attached to IUCLID section 13
4. DATA MATRIX
see “Justification for read-across” attached to IUCLID section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Species:
- rat
- Sex:
- male/female
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- 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
- Critical effects observed:
- not specified
- Remarks on result:
- not measured/tested
- 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
- Critical effects observed:
- not specified
- 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
- Critical effects observed:
- not specified
- Reproductive effects observed:
- no
- Conclusions:
- Based on read-across from structurally related source substances Polyglycerin caprylate/caprinate is not a reproductive toxicant (NOAEL >/= 2000 mg/kg bw/d).
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No experimental data are available for the target substance polyglycerin caprylate/caprinate. However, studies on toxicity to reproduction are available for the closely related source substances polyglycerol polyricinoleate and Medium chain triglycerides (MCT). A justification for read-across is given in iuclid section 13.
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 PGPR 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.
In a reproductive toxicity study, young adult male and female Wistar rats were fed a balanced diet containing 19.6% of Medium chain triglycerides (MCT) (75% caprylic and 25% capric acid) for 3 wk before mating. This group was compared to concurrent groups fed high oleo oil, butter fat or coconut oil diets. Body weight gain and litter size and birth weights of the animals on the MCT diet were similar to those of rats on the other diets. Mortality of the F1 and F2 pups during lactation was somewhat higher, and weight gain was slightly lower in the MCT diet group pups. This was directly attributed to a smaller volume of milk secreted by the dams and was supported by observations that there was considerably less body fat on these animals. After weaning, the F1 and F2 generations, which continued to be fed the MCT diet, showed a weight gain comparable to that of control rats on the other diets. There were no adverse effects on reproductive parameters or on pup development aside from slightly lower body weight gains during the lactation period.
The results are considered to be adequate to assess the reproductive toxicity of the target substance polyglycerin caprylate/caprinate. There are no data gaps for the endpoint toxicity to reproduction. There is no reason to believe that the results would not be relevant to humans.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, polyglycerin caprylate/caprinate does not need to be classified for toxicity to reproduction according to regulation (EC) 1272/2008. Thus, no labelling is required.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.