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Diss Factsheets
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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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The key GPMT study (Richeux, 2008) was performed with diglycerol using 12.5% intradermally and 100% topically for induction. After challenge, none of the animals showed a positive response.
In addition, several other studies were available, however, each study showed some deviations, limitations, and thus were considered to be supporting. In a second GPMT Test (Honack, 1996) with diglycerol, guinea pigs were induced with 5% intradermally and 100% topically. None of the guinea pigs showed signs of sensitization after challenge to 100% diglycerol, however the intradermal induction showed no skin reaction at all, and thus a higher concentration should have been used. In a third GPMT test (Chubb, 1997) with 5% diglycerol in water as test substance, guinea pigs were induced with 10% intradermally and 100% topically. After challenge with 100% of the test substance, none of the animals showed a positive response. No test substance information was available. In a fourth GPMT test (Chubb, 1996) with cycl. diglycerol, guinea pigs were induced with 20% intradermally and 100% topically. After challenge with 100% diglycerol, none of the animals showed a positive response. In a fifth GPMT test (Karunaratne, 1996) with diglycerol, guinea pigs were induced using 20% intradermally and 100% topically. After challenge with 100% diglycerol, three animals showed a positive response (30%), while none in the control group showed a response. As 30% is the limit value for considering a substance as sensitizing, it is strongly recommended according to OECD 406 to use 20 test animals and 10 control animals in this test, instead of 10 test and 5 control animals.
All tests were performed using Freund's Complete Adjuvant and sodium lauryl sulphate as prescribed by OECD 406. Thus animals were sufficiently induced.
In addition, a human patch test has been performed, showing no skin sensitisation after induction and challenge with diglycerol.
Based on the above information, the overall conclusion is that diglycerol is not sensitizing to skin.
Migrated from Short description of key information:
Four GPMT tests with diglycerol and one GPMT test with cycl. diglycerol are available. The tests have all been performed according to OECD 406 and GLP. In addition, a human patch test was available. Although one animal test showed a positive response (30% response), the overall conclusion is that diglycerol is not sensitizing to skin.
Justification for classification or non-classification
In view of the test results described above, diglycerol does not need to be classified for skin sensitization according to CLP Regulation (EC) No. 1272/2008.
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