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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 483-310-2 | CAS number: 101023-55-6
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- in vivo (LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2004-12-01 to 2004-12-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read-across from imidazole hydrobromide to imidazole hydroiodide is justified since both substances only differ in the respective counterion iodide or bromide. Both anions iodide and bromide are quite similar concerning toxicological behaviour and thus do not influence the toxicological results received.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002-04-24
- Deviations:
- yes
- Remarks:
- justification for vehicle is missing
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed May 2002
- Type of study:
- mouse local lymph node assay (LLNA)
- Justification for non-LLNA method:
- not applicable
Test material
- Reference substance name:
- 1H-Imidazole hydroiodide
- Cas Number:
- 68007-08-9
- Molecular formula:
- C3H4N2*HI
- IUPAC Name:
- 1H-Imidazole hydroiodide
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Imidazolhydroiodid
- State of aggregation: colourless - slight yellow solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (20 °C ± 5 °C), protected from light
- Stability of test item: stable under storage conditions
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst/ The Netherlands
- Females nulliparous and non-pregnant: yes
- Age: 8 - 12 weeks (beginning of acclimatization)
- Weight: 16 g - 24 g
- Housing: individual in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG)
- Diet (ad libitum): pelleted standard Kliba 3433 (batch no. 42/04 mouse maintenance diet (Provimi Kliba AG)
- Water (ad libitum): coomunity tap water from Füllinsdorf (Switzerland)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 30 - 70 %
- Air changes: 10 - 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (7/3, v/v)
- Concentration:
- 10 % (w/v), 25 % (w/v), and 50 % (w/v) of the test item
- No. of animals per dose:
- 4 female mice
- Details on study design:
- TREATMENT PREPARATION.
- test item was placed into a volumetric flask on a tared Mettler balance and the vehicle was quantitatively added.
- weight/volume dilutions were prepared individually using a magnetic stirrer as homogenizer.
- test item formulations were made freshly before each dosing occasion and no more than 4 hours prior to application to the ears.
- homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer.
PRE-SCREEN TESTS:
In a non-GLP solubility pre-test, the test item was tested in different vehicles: acetone/olive oil (4/1, v/v) and ethanol/water (7/3, v/v). A suitable vehicle (ethanol/water (7/3, v/v)) was
selected and used in the main test.
In a non-GLP conform pre-test in two female mice, test item concentrations of 5 %, 10 %, 25 % and 50 % (w/v) were tested on one ear each. After 24 hours, no irritation effects were observed at these concentrations after a single application. 50 % (w/v) was the highest technically applicable concentration in the chosen vehicle.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
Each test group of mice was treated by topical application to the dorsal surface of each ear lobe with different test item concentrations of 10 %, 25 % and 50 % (w/v) in the vehicle. The application volume, 25 μL, was spread over the entire dorsal surface (diameter: approx. 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application, all mice were administered with 250 μL of 78.42 μCi/mL ³HTdR (equal to 19.6 μCi ³HTdR) by intravenous injection via a tail vein.
Approximately five hours after treatment with ³HTdR all mice were euthanized.
The draining lymph nodes were excised and pooled for each experimental group (8 nodes/group). Single cell suspensions (phosphate buffered saline) of pooled lymph
node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 μm mesh size). After washing twice with phosphate buffered saline (approx. 10 mL) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 mL) and incubated at approx. 4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 mL) and transferred to glass scintillation vials with 10 mL of 'lrga-Safe Plus' scintillation liquid and thoroughly mixed.
The level of ³HTdR incorporation was then measured on a β-scintillation counter. Similarly, background ³HTdR levels were also measured in two 1 mL-aliquots of 5 % trichloroacetic acid. The β-scintillation counter expresses ³HTdR incorporation as the number of radioactive disintegrations/minute (DPM).
- Calculation of stimulation index:
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations/minute/lymph node (DPM/node) and as the ratio of 3HTdR
incorporated into lymph node cells of test group relative to that recorded for control group (stimulation index) (S.I.). Before DPM/node values were determined, mean
scintillation-background DPM was subtracted from test and control raw data.
Stimulation index is calculated according to the following formula:
Stimulation index (S.I.) = (dpm/LN of treated group)/(dpm/LN of control group)
- Criteria used to consider a positive response:
A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
1) exposure to at least one concentration of the test item resulted in an incorporation of ³HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
2) the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
OBSERVATIONS:
- mortality/viability: twice daily from acclimatization start to the termination of in-life phase.
- body weights: on the test day 1 (prior to the first application) and on the test day 6.
- clinical signs (locval/systemic): daily from acclimatization start to the termination of in-life phase. Particular attention was paid to the treatment sites. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- The stimulation index for the three concentrations of alpha-hexylcinnamaldehyde were as follows:
5 % (w/v): 2.7*
10 % (w/v): 3.4*
25 % (w/v): 12.4
* this value was used in calculation of EC3.
A clear dose-response relationship was observed.
A EC3 value of 7.1 % (w/v) was calculated.
Observations:
- viability/mortality: no deaths occurred during the study period.
- clinical signs: no clinical signs were observed in any animals of the control group or 5 % concentration group. On the second application day, a slight ear erythema was observed at both dosing sites in all mice of 10 % concentration group and 25 % concentration group (with the exception of one animal), persisting for the remainder of the in-Iife phase of the study or persisting for a total of three days (in two mice, on a left or a right ear), separately. On the second application day, a slight ear swelling was observed at both dosing sites in all mice of 25 % concentration group, persisting for the remainder of the in-life phase of the study or persisting for a total of three days (in one animal, on the left ear), separately.
- body weights: body weight of the animals was within the range commonly recorded for animals of the strain and age (17 g - 25 g).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- 10 % (w/v) test item
- Key result
- Parameter:
- SI
- Value:
- 2.4
- Test group / Remarks:
- 25 % (w/v) test item
- Key result
- Parameter:
- SI
- Value:
- 2.7
- Test group / Remarks:
- 50 % (w/v) test item
- Cellular proliferation data / Observations:
- No dose-response relationship was observed.
EC3 CALCULATION
Calculation of the EC3 value was not performed because no test concentrations produced a stimulation index of 3 or higher.
CLINICAL OBSERVATIONS:
- viability/mortality: no deaths occurred during the study period.
- clinical signs: no clinical signs of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
BODY WEIGHTS
The body weight of the animals was within the range commonly recorded for animals of the strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitiser.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin sensitiser.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)