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EC number: 261-605-5 | CAS number: 59113-36-9
- 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
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
- Species:
- rat
Additional information
No studies with diglycerol itself are available. See read across substances in section 12 in IUCLID for read across report.
Key study: An oral three generation reproduction study was performed with rats given 1.5% of PGPR by feed. No effects on animal growth was observed during the first 4 months of each generation. The weights of the females were recorded at weaning and mating while the weight of the males was recorded at weaning and at day 65. There were no significant differences between weights in treated or control rats. Food intake: was not recorded in this study, but a previous study indicates that levels of 5% PGPR in the diet had no effects on food intake. The rats were observed daily. There were no deaths and no evidence of abnormal behaviour or functional disorders in all 3 generations. In general for both groups the breeding performance was better in the 1st and 3rd generation. In the 2nd generation the breeding was poor in the control and PGPR group. The only significant difference was a greater percentage in the controls of litters weaned entirely which was reversed in favour of the PGPR rats in the third generation. There were no effects of PGPR on the sucking pups receiving the substance from mother's milk. Histopathology did not show any lesions. The ingestion of 1.5% PGPR in diet (equivalent to 2 g/kg bw) did not produce any adverse effects on reproductive capacity or development
of the offspring during three generations of continuous exposure. Supporting study:In a two generation study not fully matching current OECD Guidelines, male and female rats (10/treatment) were dosed daily with glycerol (20% solution in water) during 8 weeks before mating. Females received glycerol throughout pregnancy or until weaning of the F1 generation (5 each). When the F1 generation was ~100 days of age, pups were killed except for 10/sex. These animals were used to produce the F2-generation. No effects were found on the reproductive efficiency of the parents, nor on the growth, fertility, reproductive performance of the untreated F1 generation, and no histological changes occurred in the tissues of both the F1 and F2 generation. Although the data are limited, a NOAEL of >=2000 mg/kg bw was identified from this study.
Short description of key information:
Oral reproduction studies with PGPR and glycerol are available, a 3- and 2-generation reproduction study, respectively, with rats.
Effects on developmental toxicity
Description of key information
An oral developmental toxicity study with glycerol is available. The study is performed with rats, rabbits and mice.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 310 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
- Species:
- other: rats, mice and rabbits
Additional information
No study with diglycerol itself is available. Rats, mice and rabbits were treated daily with glycerol (read across substance, see section 13 of IUCLID for read across report) at dose levels up to 1310, 1280 and 1180 mg/kg bw (oral gavage), respectively, during part of the gestation period. The study protocol was in reasonable agreement with the requirements of the OECD 414 (1981). No maternal toxicity or teratogenic effects were seen at the highest dose levels tested . From this study a NOAEL for rats of >=1310 mg/kg bw can be derived. Based on the available data, there was no evidence of teratogenicity..
Justification for classification or non-classification
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.
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