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EC number: 607-089-0 | CAS number: 224789-21-3
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- - modification: in addition, measurements of ear swelling and ear weight were done to discriminate the irritating potential from the sensitizing potential of the test substance (Integrated Model for the Differentiation of Skin reactions (IMDS))
- Principles of method if other than guideline:
- Modified LLNA (IMDS; Integrated Model for the Differentiation of Skin Reactions). Modifications are authorised in the OECD TG 429 and in the Note for Guidance SWP/2145/00 of the CPMP (2001). Information on validation of IMDS and scientific justification is given in: Vohr HW et al., Arch. Toxicol., 73, 501-509 (2000); Ehling G et al., Toxicology 212, 60-68 and 69-79 (2005).
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Strain: Hsd Win:NMRI
- Housing: in groups up to 6 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): about 50
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- other: polyethylene glycol 400
- Concentration:
- 0, 1, 10, 50 %
- No. of animals per dose:
- 6
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
The test item in the formulation or the vehicle were applied epicutaneously onto the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days (d0, d1 and d2). The volume administered was 25µl/ear. The used concentrations were based on the experiences with the test system and the toxic properties of the test substance.
The animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after the last application (d3). The appropriate organs were then removed. Lymphatic organs (the auricular lymph nodes) were transferred into physiological saline (PBS).
Investigations:
- weight of draining lymph nodes (given as weight index compared to vehicle controls)
- cell counts in draining lymph nodes (given as cell count index compared to vehicle controls)
Stimulation indices were calculated by dividing the absolute weight or number of cell counts of the substance treated lymph nodes by the vehicle treated ones.
- ear swelling (given in 0.01 mm and as index)
- ear weight (given in mg/8 mm diameter punch and as index) - Positive control substance(s):
- not specified
- Statistics:
- When it was statistically reasonable, the values from treated groups were compared with those from the control group by a one-way analysis of variance (ANOVA) when the variances are considered homogeneous according to a homogeneity testing like Cochran's test. Alternatively, if the variances are considered to be heterogenous (p<=0.05), a non-parametric Kruskal-Wallis test has been used (Kruskal-Wallis ANOVA) at significance levels of 5% . Two sided multiple test procedures were done according to Dunnett or Bonferroni-Holm, respectively. Outlying values in the LN weights were eliminated at a probability level of 99% by Nalimov's method. In addition, for the LLNA/IMDS the smallest significant differentes in the means were calculated by Scheffels method, which according to Sachs can be used for both equal and unequal sample sizes.
- Parameter:
- SI
- Remarks on result:
- other: In the mid and high dose group (10 and 50 %) the "positive level" which is 1.25 for the cell count index was just met (1.25) and exceeded (1.42). The stimulation indices for the weights of the draining lymph nodes were not affected..
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
- Imidazotriazinon
was investigated in the modified local lymph node assay (LLNA-IMDS) on
female mice according to OECD TG 429. Concentrations of 0 (vehicle
control), 1, 10 and 50 % formulated in polyethylene glycol 400 were
tested. The results show that the test item has a weak sensitizing
potential in mice after dermal application. Compared to vehicle treated
animals there was an increase regarding the cell counts of the draining
lymph nodes in the mid and high dose group. A significant difference
compared to vehicle treated animals with respect to the weight of the
draining lymph nodes as well as ear swelling was not reached in any case.
Thus, a hint for a substance specific activation of the cells of the immune system via dermal application was found by the method used, i.e. the test item has a weak skin sensitizing potential.
Reference
Table 1: Summary of the LLNA/IMDS results (means of 6 animals per group)
Parameter investigated |
Vehicle control |
Dose 1 % |
Dose 10 % |
Dose 50 % |
Stimulation index: weight of draining lymph nodes |
1.00 |
0.98 |
1.10 |
1.18 |
Stimulation index: cell count in draining lymph nodes |
1.00 |
1.16 |
1.25 |
1.42 * |
Ear swelling in 0.01 mm on day 3 (index) |
18.17 (1.00) |
18.33 (1.01) |
18.58 (1.02) |
18.67 (1.03) |
Ear weight in mg / 8 mm diameter punch on day 3 (index) |
16.43 (1.00) |
15.52 (0.94) |
15.88 (0.97) |
15.08 (0.92) |
* increase exceeding "positive level" of 1.25
The mice did show a slight dose-dependent increase in the stimulation indices for cell counts but not for weight or ear swelling and ear weights. In the mid and high dose group (10 and 50 %) the "positive level" which is 1.25 for the cell count index was just met and exceeded, respectively. This classification is done despite the fact that a statistically significant increase is lacking. However, on the basis of lab experiences using this method, the "positive level" was set to an increase in cell count index by 0.25 (i.e. index >= 1.25). The "positive level" of ear swelling, which is 2x10-2 mm increase has never been reached in any case.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Imidazotriazinon
was investigated in the modified local lymph node assay (LLNA-IMDS) on
female mice according to OECD TG 429 (Vohr, 2000). Concentrations of 0
(vehicle control), 1, 10 and 50 % formulated in polyethylene glycol 400
were tested. The results show that the test item has a weak sensitizing
potential in mice after dermal application. Compared to vehicle treated
animals there was an increase regarding the cell counts of the draining
lymph nodes in the mid and high dose group. A significant difference
compared to vehicle treated animals with respect to the weight of the
draining lymph nodes as well as ear swelling was not reached in any case.
Thus, a hint for a substance specific activation of the cells of the immune system via dermal application was found by the method used, i.e. the test item has a weak skin sensitizing potential.
Migrated from Short description of key information:
Imidazotriazinon has a weak skin sensitizing potential.
Justification for selection of skin sensitisation endpoint:
Only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study results (weak skin sensitizing potential detected in a LLNA) a classification with R43 (may cause sensitization by skin contact) according to Directive 67/548/EEC or with Skin Sensitization Cat. 1B (H317: may cause an allergic skin reaction) according to Regulation (EC) No. 1272/2008 (CLP) is required.
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.
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