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EC number: 607-997-7 | CAS number: 26776-30-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-06-11 to 2007-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 29th Adaption of Guideline 67/548/EEC, B.42
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Principles of method if other than guideline:
- Modified LLNA (IMDS; Integrated Model for the Differentiation of Skin Reactions). Modification 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. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane
- EC Number:
- 607-997-7
- Cas Number:
- 26776-30-7
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane
- Test material form:
- other: liquid
- Details on test material:
- - Appearance: clear
- Physical state: liquid
- Content 72 % in solvent
Constituent 1
In vivo test system
Test animals
- 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
- Age at study initiation: 9 weeks
- Weight at study initiation: 26 - 32 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 40 - 70
- Air changes (per hr): about 10
- Photoperiod (hrs dark/ hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Remarks:
- The stability of the test item in the vehicle was analytically verified for up to 2 hours.
- Concentration:
- 50 % test item in MEK for induction and challenge phase
0.5 % DNCB (positive control) for induction and challenge phase - No. of animals per dose:
- 6
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
The test item was formulated immediately before each administration in methyl ethyl ketone.
- Induction: The test item in the formulation was applied epicutaneously onto the pre-shaven flank of the animals. This treatment was repeated on
three consecutive days (d1, d2 and d3). The volume administered was 50µl/ear.
- Challange: The test item in the formulation was applied epicutaneously onto the dorsal part of both ears of the animals. This treatment was
repeated on three consecutive days (d15, d16 and d17). The volume administered was 25µl/ear.
The animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after the last application (d18). The appropriate organs were
then removed. Lymphatic organs (the auricular lymph nodes) were transferred into physiiological saline (PBS).
Investigations:
- weight of lymph nodes
- cell counts in lymph nodes
- stimulation index is calculated by dividing the absolute number of weight or cell counts of the substance treated lymph nodes by the vehicle treated ones.
- ear swelling
- ear weight - Positive control substance(s):
- other: 1-Chloro-2,4-dinitrobenzene (DNCB) CAS-No: 97-00-7
- Statistics:
- When it was statistically reasonable, the values from treated groups were compared with those from the control group(s; vehicle) by a one-way
analysis of variance (ANOVA) when the variances are considered homogeneous according to an homogeneity testing like Cochrans test. Outlying
values in the LN weights were eliminated at a probability level of 99% by Nalimov's method (Statistik für naturwissenschaftliche Berufe, 1982, 88-89).
In addition, for the LLNA/IMDS the smallest significant differentes in the means were calculated by Scheffe's method (Biometrica 40, 1953, 87-104),
which according to Sachs (Angewandte Statistik 6th and 10th edition, Springer Verlag, Berlin, 1978/2002 ) can be used for both equal and unequal
sample sizes.
Results and discussion
- Positive control results:
- Performed in 2002. The "positive level" which is 1.3 for cell counts has been statistically significant exceeded in the highest dose group (30%).
(Cell index/concentration: 0.88 / 3%; 1.13/ 10%; 1.77/ 30%)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The "positive level" which is 1.4 for the cell index was statistically significant exceeded after application of 0.5 % DCNB
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: modified LLNA; measurement of cell counts instead of radioactive labeling
Any other information on results incl. tables
The body weights of the animals were not affected by any treatment.
Applicant's summary and conclusion
- Conclusions:
- Sensitizing property can be excluded after application of 50 % concentration of the test item for induction and challenge.
- Executive summary:
The aim of these investigations was to verify any specific (sensitizing) stimulating potential of the test item as assumed after primary response investigations (Bayer AG, 2003).
A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of the test item for 3 consecutive days, each onto the flank (induction) and both ears (challenge) of the animals. Application with the positive control compound DNCB led to the effects expected after specific challenge, i.e. significant increase in cell counts and ear swelling compared to primary response. Compared to vehicle treated animals there was a clear increase in cell counts in group 2 (vehicle/test item). This change is of statistical significance and the "positive level" of index 1.4 has been exceeded. In contrast, cell count indices of challenge (group 3, 2x test item) did not reach or exceeded this cut-off. The "positive level" of ear swelling has been exceeded in group 2 and 3. These increases are of statistical significance. A significant increase compared to vehicle treated animals regarding ear weights was detected in these groups, too.
Taken together, no activation of antigen specific cells via dermal route was determined after challenge application of
the test item by the used method.
In conclusion, these results show that the test item has an irritant potential in mice after dermal application of a 50% concentration, while a specific memory development has not been observed. Therefore, a sensitizing property can be excluded after application of 50 % concentration of the test item for induction and challenge. These results are verified by the comparision with the results of the positive control group.
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