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Diss Factsheets
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EC number: 939-489-9 | 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
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Skin sensitisation
Administrative data
- 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: modern guideline study conducted under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen
- EC Number:
- 939-489-9
- Molecular formula:
- C7 H16 N2
- IUPAC Name:
- Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen
- Test material form:
- liquid
- Details on test material:
- Test Item (as cited in study report): Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen
BASF Test Item No.: 10/0117-4
Batch Number: 73583556P0
CAS-No.: 13897-55-7 and 13897-56-8
Purity: Mixture of isomers (in total > 99%)
Physical state, colour: Liquid / yellowish, clear
Homogeneity: The test item was homogeneous by visual inspection.
Storage conditions: Room temperature
Expiration Date: November 14, 2015
Density [g/mL]: 0.929
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 2, 5, and 10%
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- vehicle control
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 2% test substance
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 5% test substance
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 10% test substance
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- positive control hexyl cinnamic aldehyde
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: mean BrdU laeling index: vehicle control: 0.105 2% MDACH in PG: 0.091 5% MDACH in PG: 0.108 10% MDACH in PG: 0.113 positive control (hexyl cinnamic aldehyde): 0.295
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen was thus not a skin sensitiser under the test conditions of this study.
- Executive summary:
The study was conducted to assess the skin sensitizing potential of the test item Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen using the Local Lymph Node Assay (LLNA) in mice. Test item solutions at different concentrations were prepared in the vehicle propylene glycol (PG).
The local lymph node assay is recommended by international test guidelines (e.g. OECD) as an animal test for predicting skin sensitization in humans and provides a rational basis for risk assessment. The basic principle underlying the LLNA is that sensitizers induce a primary proliferation of lymphocytes in the lymph node draining the application site. The ratio of proliferation in test item treated groups compared to that in vehicle controls is termed the Stimulation Index (S.I.). BrdU labeling is used to measure cell proliferation.
For this purpose a local lymph node assay was performed using test item concentrations of 2, 5 and 10% (w/w; weight per weight). Doses based on previously performed two pre-tests in the same animal strain. Two mice per concentration were treated epicutaneously with test item concentrations of 2.5, 5, 10 and 25 % (w/w) each on three consecutive days. Signs of systemic toxicity were not observed in any of the pre-tests. At the tested concentration of 25% the animals showed signs of local irritation as confirmed by the ear weight measurements. Both animals in this dose group showed increased ear weights > 25%. In the 10% dose group both animals showed body weight loss > 5%. Due to the fact that the animals in the 25% dose group did not show a body weight loss beyond the threshold, it is likely and assumed that body weight loss in the 10% group is an incidental finding without any effects for the study. In the 2.5 and 5% group the measured values were below the cut-off values.
The following dose levels were selected for the main study: 2%, 5% and 10% (w/w) in propylene glycol. Additionally, a positive control group (25% hexyl cinnamaldehyde in propylene glycol, w/w) was also applied.
In the main study the animals did not show any relevant signs of systemic toxicity during the course of the study and no cases of mortality were observed. A statistically significant or biologically relevant increase in ear weights was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cut-off-value for a positive response (irritation) regarding the ear weight index of 1.25 was not exceeded in any dose group.
A test item is regarded as a sensitizer in the LLNA if exposure to one or more test item concentration results in a 1.6-fold or greater increase in incorporation of BrdU compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated test item concentration required to produce a S.I. of 1.6 is referred to as the EC1.6 value.
In this study Stimulation Indices (S.I.) of 0.9, 1.0 and 1.1 were determined with the test item at concentrations of 2, 5 and 10 % (w/w) in propylene glycol. An EC1.6 value could not be determined as all S.I.s obtained were below the threshold of 1.6.
A statistically significant or biologically relevant increase in the BrdU value and also in lymph node weight and cell count was not observed in any of the tested dose groups in comparison to the vehicle control group. Furthermore, the cutoff-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice was not exceeded in any of the tested dose groups.
As expected, a statistical and biological relevant increase in BrdU labelling, lymph node weight, lymph node cell count and ear weight measurement was determined in the positive control. For the positive control a S.I of 2.8 was determined.
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