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EC number: 700-457-2 | 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
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: According to GLP; OECD-guideline 429; 2004/73/EC, B.42.; US EPA OPPTS 870.2600.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
- EC Number:
- 700-457-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
- Details on test material:
- - Name of test material (as cited in study report): LIMUS-Sambaydestillation
- Test-substance No.: 07/0684-1
- Physical state: solid/yellowish
- Analytical purity: 87%
- Lot/batch No.: 8712 / 062
- Storage condition of test material: < -18°C
- Stability: stable over 5 days
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 6 - 12 weeks
- Weight at study initiation: 18.9 - 21.4 g
- Housing: Makrolon cage, type II
- Diet (e.g. ad libitum): Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 0, 3, 10 and 50% of the test substance in MEK (methyl ethyl ketone)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: the results of a pretest with a 50% test-substance preparation in MEK (methyl ethyl ketone) were considered, which showed some increase in lymph node weights without definitive increased ear weights which is still interpreted as indication of ear skin irritation. Higher concentrations we re not tested in order to avoid ear skin irritation and because the 50% concentration is a suspension and well above the effect level of mild to moder ate skin sensitizers, leading to a sufficiently stringent conduct of the study.
MAIN STUDY
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 5 female CBA/J mice each were treated with 3%, 10% and 50% w/w preparations of the test substance in MEK (methyl ethyl ketone) or with the vehicle alone. The study used 3 test groups and 1 control group. Each test animal was applied with 25 μL per ear of the respective test-substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone. Three days after the last application the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μL of sterile saline into a tail vein. About 5 hours after the 3H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. The weights of each animal’s pooled lymph nodes were determined. Thereafter lymph nodes were pooled group wise and further evaluated by measuring their cellular content and 3H-thymidine incorporation into the lymph node cells (indicators of cell proliferation). Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each test group the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation. - Positive control substance(s):
- other: A concurrent positive control (reliability check) with a known sensitizer was not included into this study. Studies using the positive control substance Alpha-Hexylcinnamaldehyde are performed twice a year in the laboratory in order to show that the test.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see discussion
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table in any other information on results incl tables
Any other information on results incl. tables
Test group |
Treatment |
Cell Count Stimulation Index |
3H-thymidine incorporation Stimulationindex |
Lymph Node Weight StimulationIndex |
Ear Weight Stimulation Index |
1 |
vehicle MEK |
1.00 |
1.00 |
1.00 |
1.00 |
2 |
3% in MEK |
1.20 |
1.64 |
1.07 |
1.01 |
3 |
10% in MEK |
1.23 |
2.54 |
1.26 |
1.02 |
4 |
50% in MEK |
1.90 |
9.11 |
1.75 |
1.08 |
The threshold concentraton for sensitization iduction was >10% <50%. The estimated concentraton that leads to the SI of 1.5 for cell count (ECC 1.5) and the estimated concentration that leads to the SI of 3.0 for 3H-thymidine incorporation (EC 3) were calculated by linear regression from the results of the 10% and 50% concentrations to be 26.1% and 12.8%, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Thus it is concluded that LIMUS-Sambaydestillation shows a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen. According to the findings of this study, the test substance has to be classified R43 (Directive 67/548/EEC) and Skin sensitisation Cat. 1 (GHS (UN)).
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