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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-101-2 | CAS number: 1739-84-0
- 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
Genetic toxicity in vitro
Description of key information
An increase in the number of his+ or trp+ revertants was not observed in
the standard plate test either with or without S-9 mix. Therefore, the
test substance is not mutagenic in the Ames test under the experimental
conditions chosen.
Under the experimental conditions reported the test item did not induce
gene mutations at the HPRT locus in V79 cells. Therefore, the test
substance is considered to be non-mutagenic in this HPRT assay.
It can be stated that under the experimental conditions reported, the
test substance did not induce micronuclei in V79 cells (Chinese hamster
cell line) in vitro in the absence and presence of metabolic activation.
Therefore, the test substance is considered to be non-mutagenic in this
in vitro test system, when tested up to the highest required or
evaluable concentrations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
No information available.
Additional information
1,2-Dimethylimidazole was tested in the Ames reverse mutation assay (GLP compliant study according to OECD guideline 471 and 472) using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvr A at 20 to 5000 µg/plate (standard plate and preincubation test) with and without metabolic activation (1998; RL1). Under the conditions tested,1,2-dimethylimidazole was not mutagenic in any of the S. typhimurium strains and E.coli WP2 uvr A.
In a GLP-compliant study performed according to OECD guideline 476 the test item was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster (2013; RL1). The study was performed in two independent experiments, using identical experimental procedures. In the first experiment the treatment period was 4 hours with and without metabolic activation (assayed concentrations 62.5, 125.0, 250.0, 500.0 and 1000.0 µg/mL). The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation (assayed concentrations: 62.5, 250.0, 500.0 and 1000.0 µg/mL (4h with S9), and 31.3, 62.5, 125.0, 250.0 µg/mL (24h without S9)). The test item was dissolved in deionised water. In the experimental part of the second experiment without metabolic activation (24 hour treatment) the concentration range was limited by cytotoxic effects. Relevant cytotoxic effects indicated by a relative cloning efficiency I or cell density below 50% in both parallel cultures occurred in the second experiment at 125 and 250 μg/mL without metabolic activation. The recommended cytotoxic range of approximately 10-20% relative cloning efficiency I or relative cell density was covered. In all of the experimental parts using 4 hours treatment with and without metabolic activation the concentration range went up to 1000 μg/mL or approximately 10 mM. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Appropriate reference mutagens (EMS and DMBA), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system. In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test substance is considered to be non-mutagenic in this HPRT assay.
In
a GLP-compliant study, performed according to OECD guideline 487, the
test substance (dissolved in deionised water) was assessed for its
potential to induce micronuclei in V79
cells
of the Chinese hamster in vitro in the absence and presence of metabolic
activation by S9 mix (2013; RL1). Four independent experiments were
performed. In Experiment IA the exposure period was 4 hours with and
with out metabolic activation. In Experiment IB the exposure period was
4 hours with metabolic activation. In Experiment IIA and IIB the
exposure periods were 24 hours without S9 mix and 4 hours with metabolic
activation. The cells were prepared 24 hours after start of treatment
with the test item. In each experimental group two parallel cultures
were set up and at least 1000 cells per culture were scored for
micronuclei. The highest applied concentration (1000.0 µg/mL; approx. 10
mM) was chosen with regard to the molecular weight and the preliminary
purity (96.0 %) of the test item and with respect to the OECD Guideline
No. 487. No visible precipitation of the test item in the culture medium
was observed. No relevant influence on osmolarity was observed. Phase
separation was observed microscopically in the presence of S9 mix in
Experiment IIA at 600.0 µg/mL and above and in Experiment IIB at 900.0
µg/mL and above at the end of treatment. The pH was adjusted to
physiological values. In Experiment IA in the absence of S9 mix and in
Experiment IB and IIB in the presence of S9 mix no cytotoxicity was
observed up to the highest applied concentration. In Experiment IA in
the presence of S9 mix, in Experiment IIA in the absence and presence of
S9 mix and in Experiment IIB in the absence of S9 mix concentrations
showing clear cytotoxic effects were not evaluable for cytogenetic
damage. In Experiment IA in the presence of S9 mix increases in
micronucleated cells above the range of the laboratory historical
control data (0.05 - 1.70 % micronucleated cells) were observed after
treatment with 62.5 and 125.0 µg/mL (2.13 and 1.80 % micronucleated
cells).The
values were not statistically significant. In
Experiment IB these findings could not be confirmed. All values were
within the range of the laboratory historical control data (0.05 -1.70 %
micronucleated cells) and were not statistically significant. In
Experiment IIA in the absence of S9 mix one statistically significant
increase, clearly exceeding the laboratory historical solvent control
data range (without S9 mix: 0.15 – 1.50 % micronucleated cells) was
observed after treatment with 250.0 µg/mL (3.18 %). In the presence of
S9 mix increases above the laboratory historical solvent control data
range (with S9 mix: 0.05 – 1.70 % micronucleated cells) were observed
after treatment with 600.0, 700.0 and 800.0 µg/mL (1.90, 1.83 and 2.13
%, respectively). The highest value was statistically significant. In
the confirmatory Experiment IIB in the absence of S9 mix statistically
significant increases (1.15, 1.15, 1.00 % micronucleated cells) within
the laboratory historical solvent control data range (0.15 – 1.50 %
micronucleated cells) were observed after treatment with 325.0, 350.0
and 400.0 µg/mL. In the presence of S9 mix one statistically significant
increase (1.15 % micronucleated cells) within the laboratory historical
solvent control data range (0.05 –1.70 % micronucleated cells) was
observed after treatment with 1000.0 µg/mL and thus the findings could
not be confirmed. Appropriate mutagens were used as positive controls.
They induced statistically significant increases in the percentage of
micronucleated cells. In conclusion, it can be stated that under the
experimental conditions reported, the test substance did not induce
micronuclei in V79
cells
(Chinese hamster cell line) in vitro in
the absence and presence of metabolic activation. Therefore, the test
substance is considered to be non-mutagenic in this in vitro test
system, when tested up to the highest required or evaluable
concentrations.
Justification for classification or non-classification
Based on the results of the available data, 1,2-dimethylimidazole does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.