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EC number: 221-391-6 | CAS number: 3084-40-0
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- n/a
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Diethyl (hydroxymethyl)phosphonate
- EC Number:
- 221-391-6
- EC Name:
- Diethyl (hydroxymethyl)phosphonate
- Cas Number:
- 3084-40-0
- Molecular formula:
- C5H13O4P
- IUPAC Name:
- diethyl (hydroxymethyl)phosphonate
- Test material form:
- other: meduim viscosity liquid
- Details on test material:
- E06-16 (Lot# 1041-37-6, Sample: T# 207), transparent "medium-viscoosity" liquid.
Constituent 1
- Specific details on test material used for the study:
- Lot number 540-1013-14
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Healthy female CBA/Ca mice (a total of 34 females) from Harlan Netherlands Ltd.
weight range: 17.0 to 22.4 g a
eight to twelve weeks of age
Acclimatisation to experimental environment: at least 6 days prior to the start of the study.
Two or three animals per cage
Temperature and relative humidity: range of 19 to 23oCC and 40 to 70% respectively.
Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 50% v/v
- No. of animals per dose:
- 5
- Details on study design:
- The study comprised of three treated groups, each comprising five female mice receiving E06-16 at concentrations of 25, 50% v/v and the test substance as supplied. Similarly constituted groups received a sham dose (naïve control), the vehicle dimethylformamide (DMF) or positive control substance (25% v/v hexyl cinnamic aldehyde).
The mice were treated by daily application of 25 uL of the appropriate concentration or control (vehicle or positive), to the dorsal surface of both ears for three consecutive days. The naïve control were not dosed with test substance or vehicle, just the tip of the pipette passed over the ears on each dosing occasion.
The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-methyl Thymidine (3HTdR) by beta-scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio), termed as Stimulation Index (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical Analysis of Radioactivity Data (dpm) for the E06-16 Local Lymph Node Assay was performed.
Varous tests were applied as follows: Bartlett’s test, Dunnett's test Shirley's test, Steel's test, Wilcoxon rank sum test and t-test.
Results and discussion
- Positive control results:
- The SI for the positive control substance hexyl cinnamic aldehyde was 9.2, which demonstrates the validity of this study.There was a significant increase in mean dpm for the HCA treated group in comparison with the vehicle control (p=0.001).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- >= 0.7
- Test group / Remarks:
- 5 animals
- Remarks on result:
- other: 25% v/v
- Key result
- Parameter:
- SI
- Value:
- >= 1
- Test group / Remarks:
- 5 animals
- Remarks on result:
- other: 50% v/v
- Key result
- Parameter:
- SI
- Value:
- >= 2.2
- Test group / Remarks:
- 5 animals
- Remarks on result:
- other: as supplied
- Cellular proliferation data / Observations:
- Product: DPM*/node SI
vehicle DMF 237.5 n/a
Naive control 181.6 n/a
25% v/v E06-16 167.6 0.7
50% v/v E06-16 232.7 1.0
E06-16 As supplied 391.8 2.2
HCA 25% v/v 2191.5 9.2
*dpm- Disintegrations per minute (less background count of 43.0 dpm)
Any other information on results incl. tables
There was no evidence of a treatment effect for the E06-16 treated groups when compared with the appropriate control group. This result was consistent with stimulation indices less than 3 for these groups.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- E06-16 is not regarded as a potential skin sensitizer
- Executive summary:
The study was performed to assess the skin sensitization potential of E06-16 using the local lymph node assay (LLNA).
The study comprised of three treated groups, each comprising five female mice receiving E06-16 at concentrations of 25, 50% v/v and the test substance as supplied. Similarly constituted groups received a sham dose (naïve control), the vehicle dimethylformamide (DMF) or positive control substance (25% v/v hexyl cinnamic aldehyde). The mice were treated by daily application of 25 uL of the appropriate concentration or control (vehicle or positive), to the dorsal surface of both ears for three consecutive days. The naïve control were not dosed with test substance or vehicle, just the tip of the pipette passed over the ears on each dosing occasion.
The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-methyl Thymidine (3HTdR) by -scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio), termed as Stimulation Index (SI). The test substance is regarded as a sensitizer if at least one concentration of the chemical has a SI of three or more.
Results
The SI obtained for 25, 50% v/v and as supplied were 0.7, 1.0 and 2.2 respectively which indicates that E06-16 did not show the potential to induce skin sensitization. The SI for the positive control substance hexyl cinnamic aldehyde was 9.2, which demonstrates the validity of this study.
Conclusion
E06-16 is not regarded as a potential skin sensitizer.
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