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EC number: 266-235-8 | CAS number: 66204-44-2
- 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
Additional information
The substance was not mutagenic in genotoxicity assays in the bone marrow of mice. This indicates that the substance is not genotoxic distant from the site of first contact. However, mutagenicity assays in vitro reveal the reactivity of the substance towards DNA which corresponds to the reactivity of formaldehyde. Data on the hydrolysis product formaldehyde suggested more local than systemic mutagenic effects. Formaldehyde is genotoxic in vitro and it induces local clastogenic effects in vivo.
Short description of key information:
In Vitro
In the Salmonella microsome assay according to OECD 471 (Müller 1997 &
Rajwani 2000) the test substance did not induce gene mutation in
bacteria with and without metabolic activation. However, the test
substance was not tested up to the cytotoxicity threshold limiting the
validity of these studies.
In a 3rd Salmonella microsome assay (Bowles 2000, OECD guideline 471) an
increased number of revertants was detected in TA98, TA100, and WP2uvrA
with and without metabolic activation also at non-cytotoxic
concentrations. But this increase was maximal 2-fold of the concurrent
control indicating only weak mutagenic activity.
In the chromosome aberration test (OECD guideline 473; Wright 2001) the
test substance has clastogenic activity and induces polyploidy even at
non-cytotoxic concentrations with and without metabolic activation.
Accordingly, predominantly chromosome mutagenic activity (increase in
small colonies) was demonstrated in two independent mouse lymphoma tests
with and without metabolic activation (Nolan, 2002& Durward/Noan 2001).
In Vivo
In the cytogenetic study (Mukherjee 2000; OECD guideline 475) a slight
increase in % aberrant cells was observed but this effect was not
statistically significant. The authors concluded that the test result
was negative. It might be questioned, whether the maximum tolerated dose
was reached in this study since 1) all animals were found to be without
clinical symptoms after exposure and 2) no decrease in mitotic index was
observed. No details were given about the determination of the MTD. In
conclusion, ambiguous test results were presented in this study.
In a valid micronucleus test according to OECD guideline 474 (Leuschner
2002) no increase in the number of micronuclei at a dose level up to 300
mg/kg bw, the maximum tolerated dose, was detected indicating no
aneugenic or clastogenic activity of the test substance.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
So far no labelling exist for the substance because the content of free formaldehyde is <1%; use concentrations were hydrolysis will occur are low and released formaldehyde is assumed to be again <1%.
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