Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 211-063-0 | CAS number: 628-96-6
- 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:
A human study using EGDN is available indicating that EGDN has a low skin sensitising potential.
Skin sensitization may be observed in some patients exposed to EGDN (Kanerva et al. 1991). However, the likelihood of occurrence among the exposed population appears to be low.
The guinea pig study conducted with NG suggests that NG is sensitizing.
Guinea pigs (10 per group) were first sensitized intradermally on d0, and again topically on d7 (Lee et al. 1975). On d21 the animals were challenged topically with a closed patch for 24 h and readings were taken 24 h and 48 h post-challenge. A control group received the same induction and challenge applications excluding the test agent (generic guinea pig maximization test description).Using a dermal application of 3.41% NG in lactose/peanut oil carrier, “moderate” skin sensitization was observed in 40% of guinea pigs in the treatment group. However, the study is not valid (Klimisch 3) since there is no information on the animal strain used, no information on the induction and elicitation concentrations and information is lacking on the reactions of control animals. This evaluation is in line with the assessment of the German MAK commission, which also considered the guinea pig test as not reliable and not valid (MAK Value Documentation - Glycerintrinitrat, 2006).
Overall, it is concluded that EDGN does not warrant a classification for skin sensitisation. This is in line with the current entry in Annex VI Table 3 of Regulation (EU) 1272/2008.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No studies specifically assessing respiratory sensitization for EGDN or NG (read-across) were available. But, given that no secondary sources reporting on inhalation exposures identified respiratory sensitization as an adverse effect, EGDN is not considered to be a likely respiratory sensitizer.
Justification for classification or non-classification
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