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EC number: 279-976-7 | CAS number: 82486-82-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07/02/2018 - 12/02/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[butyl(nitro)amino]ethyl nitrate
- Cas Number:
- 82486-82-6
- Molecular formula:
- C6H13N3O5
- IUPAC Name:
- 2-[butyl(nitro)amino]ethyl nitrate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Chemring / Batch 02/16
- Expiration date of the lot/batch: 01 January 2021
- Purity test date: 100%
- Physical state/Appearance: Yellow liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle: The test item was used as supplied.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was used as supplied.
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS:
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: NA
- Source strain:
- other: Epiderm Reconstructed Human Epidermis Model Kit
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKIN™ Reconstructed Human Epidermis Model Kit
Supplier : EpiSkin Laboratories, Lyon, France
Date received : 06 February 2018
EpiSkinTM Tissues (0.38cm2) lot number : 18-EKIN-006
Maintenance Medium lot number : 18-MAIN3-005
Assay Medium lot number : 18-ESSC-005 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 per assay
Test animals
- Species:
- other: NA
- Strain:
- other: NA
- Details on test animals or test system and environmental conditions:
- NA
Test system
- Type of coverage:
- other: NA
- Preparation of test site:
- other: NA
- Vehicle:
- other: NA
- Controls:
- other: NO
- Amount / concentration applied:
- NA
- Duration of treatment / exposure:
- NA
- Observation period:
- NA
- Number of animals:
- NA
- Details on study design:
- NA
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 min exposure
- Value:
- ca. 130.8
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 5.0% relative to the negative control treated tissues and the standard deviation value of the viability was 2.9%. The positive control acceptance criteria were therefore satisfied.
The mean OD570 for the negative control treated tissues was 0.807 and the standard deviation value of the viability was 4.1%. The negative control acceptance criteria were therefore satisfied.
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 14.1%. The test item acceptance criterion was therefore satisfied.
Any other information on results incl. tables
RESULTS
Direct MTT Reduction
The MTT solution containing the test item did not turn blue or purple which indicated that the test item did not directly reduce MTT.
Assessment of Color Interference with the MTT endpoint
The solution containing the test item was a yellow color, therefore additional color correction tissues were incorporated into the testing procedure. However, the results obtained showed that no color interference occurred. It was therefore considered unnecessary to use the results of the color correction tissues for quantitative correction of results or for reporting purposes.
Test Item, Positive Control Item and Negative Control Item
The individual and mean OD570 values, standard deviations and tissue viabilities for the test item, negative control item and positive control item are given in Appendix 1. The mean viabilities and standard deviations of the test item and positive control, relative to the negative control are also given in Appendix 1.
The relative mean viability of the test item treated tissues was 130.8% after a 15-Minute exposure period and 42-Hour post-exposure incubation period.
It was considered unnecessary to perform IL-1α analysis as the results of the MTT test were unequivocal.
Appendix 1 Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD570 of individual tissues | Mean OD570 of triplicate tissues | SD of OD570 | Relative individual tissue viability (%) | Relative mean viability (%) | */- SD ofRelative Mean Viability (%) |
Negative control | 0,78 | 0,807 | 0,033 | 96,7 | 100 | 4,1 |
0,844 | 104,6 | |||||
0,796 | 98,7 | |||||
Positive control | 0,021 | 0,04 | 0,023 | 2,6 | 5 | 2,9 |
0,066 | 8,2 | |||||
0,033 | 4,1 | |||||
Test item | 1,154 | 1,055 | 0,113 | 143,1 | 130,8 | 14,1 |
0,932 | 115,5 | |||||
1,08 | 133,9 |
Classification of irritation potential is based upon relative mean tissue viability following the 15-Minute exposure period followed by the 42-Hour post-exposure incubation period : prediction irritant if the relative mean tissue viability is < or = 50% (cat 1 or 2 under UN GHS) and prediction non irritant in the contrary case (Category 3 cannot be determined under US GHS).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was classified as non-irritant. The following classification criteria apply: UN GHS Not classified for Irritation (category 3 can not be determined).
- Executive summary:
In a in vitro EPISKIN study (Lacey F.E, 2018), performed according to the OECD 439 Guideline and in compliance with GLP, Triplicate tissues were treated with the Butyl-NENA for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. The test item was found to have the potential to cause color interference with the MTT endpoint therefore additional tissues were incorporated into the testing to correct for this.
At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labeled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 μL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density was measured at 570 nm.
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viability of the test item treated tissues was 130.8% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
The test item was therefore classified as non-irritant. The following classification criteria apply: UN GHS Not classified for Irritation (category 3 can not be determined).
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