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EC number: 916-226-6 | CAS number: -
- 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
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Katalysator W AZ 5596-B.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Vehicle:
- dimethylformamide
- Concentration:
- Group 1 Vehicle (DMF)
Group 2 2% Katalysator W AZ 5596-B (in DMF)
Group 3 10% Katalysator W AZ 5596-B (in DMF)
Group 4 50% Katalysator W AZ 5596-B (in DMF)
Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in DMF) - No. of animals per dose:
- 6 animals/test item group and 6 control animals
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429. 1. Direct LLNA (NMRI mice, female, 6 animalsl group) Groups Weight index Cell count index (index of mean +/-SD in %) Gr.l 1.00 +/-27.79 1.00 +/-32.01 Gr.2 1.88 +/-11.46 1.78 +/-14.11 Gr.3 1.68 +/-39.95 1.84 +/-35.98 Gr.4 1.69 +/-43.54 1.08 +/-65.67 Gr. 5 2.01 +/-29.30 2.39 +/-36.11 Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Groups day 1 day4 Index day4 (mean +/- SD in %) Gr. 1 17.25 +/- 2.62 17.67 +/- 2.79 1.00 Gr.2 17.25 +/- 3.60 18.67 +/- 6.98 1.06 Gr. 3 17.33 +/- 3.76 21.42 +/- 15.61 1.21 Gr. 4 17.33 +/- 5.12 36.92 +/- 16.31 2.09 Gr. 5 17.50 +/- 3.85 26.75 +/- 25.01 1.51 Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Groups day4 Index day4 (mean +/- SD in %) Gr.1 12.32 +/- 8.82 1.00 Gr.2 14.77 +/- 6.56 1.20 Gr.3 18.47 +/- 8.63 1.50 Gr.4 34.57 +/- 9.64 2.81 Gr.5 19.53 +/- 17.97 1.59 Group 1 Vehicle (DMF) Group 2 2% Katalysator W AZ 5596-B (in DMF) Group 3 10% Katalysator W AZ 5596-B (in DMF) Group 4 50% Katalysator W AZ 5596-B (in DMF) Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in DMF)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not applicable
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/ test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of
the test item Katalysator WAZ 5596-B.
This study was carried out with NMRI mice from commercial breeder Charles River Germany, which is not the normally used breeder of the lab. Therefore, a concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included.
The study was conducted according to OECD Guidelines No. 429 and No. 406, EC Guideline 2004173IEC (29th Adaptation of Guideline 67/548/EEC, B.42)/Health Effects Test Guideline and OPPTS 870.2600 (EPA) with the following test item concentrations:
Test item: 0 % (vehic1e control), 2 %, 10 % and 50 %. Positive control: 30 % Alpha Hexyl Cinnamic Aldehyde. The test item was formulated in dimethylformarnide (DMF) to yield a solution.
Compared to vehicle treated animals there was a clear increase regarding the weights of the draining lymph nodes, which is of statistical significance in the low dose group and a clear increase in the cell counts, which is of statistical significance in the low and the rnid dose group. The "positive level" of index 1.4 for the cell counts has been exceeded in the low and the mid dose group.
The "positive level' of ear swelling which is 2x 10-2 mm increase, i.e. about 10% of the control values, has been exceeded in the rnid and the high dose group. These changes are of statistical significance. A significant increase compared to vehicle treated animals regarding ear weights was detected in all dose groups. An increase in this parameter would point to an acute irritating (inflammatory) response. However, such an irritant property could also be combined with a skin sensitizing potential of a test compound.
In conclusion, these results show that the test item Katalysator W AZ 5596-B has a sensitizing potential in mice after dermal application of a 2 % concentration.
Although it is not possible to calculate an exact EC value from the data obtained, it is clear that the EC value is in any case below 2%.
These results are verified by the comparison with the results of the positive control group (Alpha Hexyl Cinnarnic Aldehyde).
Reference
A sensitizing potential can be assumed from the increases in cell proliferation in the draining lymph nodes. On the basis of our experiences using this method the "positive level" had been set to an increase in cell count index by 0.4 (i.e. index >1.4), which has been exceeded in the low and the mid dose group. Differentiation indices (DI), which is the quotient of the relative lymph node reaction divided by the relative acute skin reaction were > 1 for the low and the mid concentration tested, i. e. 3.25, and 1.00, respectively . These DI values do point to a sensitizing potential ofthe test item.
The "positive level" of ear swelling which is 2x 10-2 rnm increase, i.e. about 10% of the control values, has been exceeded in the mid and in the high dose group. An increase in this parameter does point to an acute irritant (inflammatory) response. Due to
the strong irritant property of the test item at these concentrations it is not quite clear if the cell proliferation is partly induced by this non-specific (inflammatory) reaction. On the other hand effects measured at the low concentration (2%) clearly point to a sensitizing property of the test item.
Although it is not possible to calculate an exact EC value from the data obtained, it can be assumed that the EC value is in any case below 2%. In accordance with the classification proposed in the Technical Report No. 78 of the ECETOC this value corresponds to at least a moderate skin sensitizer.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A sensitizing potential can be assumed from the increases in cell proliferation in the draining lymph nodes. On the basis of experiences by the author of the study using this method the "positive level" had been set to an increase in cell count index by 0.4 (i.e. index>1.4), which has been exceeded in the low and the mid dose group.
The "positive level" of ear swelling which is 2x 10E-2 mm increase, i.e. about 10% of the control values, has been exceeded in the mid and in the high dose group. An increase in this parameter does point to an acute irritant (inflammatory) response. Due to
the strong irritant property of the test item at these concentrations it is not quite clear if the cell proliferation is partly induced by this non-specific (inflammatory) reaction. On the other hand effects measured at the low concentration (2%) clearly point to a sensitizing property of the test item.
These results are verified by the comparison with the results of the positive control group (Alpha Hexyl Cinnarnic Aldehyde).
Migrated from Short description of key information:
A modified Local Lymph Node Assay (IMDS) indicate some sensitisation potential. At higher concentrations irritation was observed.
Justification for selection of skin sensitisation endpoint:
key study is used
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
no data
Migrated from Short description of key information:
no data
Justification for classification or non-classification
Due to the positive result of the LLNA a classification as R43 (GHS: Skin Sens 1a) ist justified
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