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EC number: 417-560-0 | CAS number: 67881-98-5
- 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 (non-LLNA)
- Type of information:
- other: Letter of Access (See Section 13)
- Adequacy of study:
- key study
Data source
Reference
- Reference Type:
- other: Letter of Access (See Section 13)
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- not specified
- Remarks:
- Letter of Access Only
- Type of study:
- Freund's complete adjuvant test
Test material
- Reference substance name:
- -
- EC Number:
- 417-560-0
- EC Name:
- -
- Cas Number:
- 67881-98-5
- Molecular formula:
- C11H22NO6P
- IUPAC Name:
- trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- At induction, an intradermal injection of 10 % (w/w) in water was used and a topical application of 95.2 % (w/w) in distilled water.
The single challenge dose was applied topically at two concentrations: 60 % and 30 % (w/w) in distilled water.
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- At induction, an intradermal injection of 10 % (w/w) in water was used and a topical application of 95.2 % (w/w) in distilled water.
The single challenge dose was applied topically at two concentrations: 60 % and 30 % (w/w) in distilled water.
- No. of animals per dose:
- 10 animals per dose group and 5 animals in the negative control group.
- Challenge controls:
- 5 animals were used as a control group for each of the two test concentrations.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 % (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % (w/w). No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 % (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % (w/w). No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 % (w/w)
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % (w/w). No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 % (w/w)
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % (w/w). No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60 % (w/w)
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 % (w/w). No with. + reactions: 1.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 % (w/w). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 % (w/w). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 % (w/w). No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Signs of irritation during induction:
Intradermal injection: Necrosis was recorded at sites receiving Freud's Complete Adjuvant in test and control animals. Slight irritation was seen in test animals at sites receiving the HEMA-PC, 10 % (w/w) in water for irrigation. No irritation was observed in control animals receiving water for irrigation.
Topical Application: Slight erythema was observed in test animals following application of HEMA-PC, 95.2 % (w/w) in distilled water. Very slight erythema was seen in the control group animals.
Table 1. Results of Skin Sensitisation Challenge
Number of animals showing sjin reactions |
|||
1st Challenge |
|||
Challenge Concetration of Test Substance (% w/w) |
24 hour |
48 hour |
|
Test Group |
60 30 |
10 7 |
10 5 |
Negative Control Group |
60 30 |
1 0 |
0 0 |
Other Observations:
No signs of inn-health or toxicity were recorded.
Comments:
The dermal reactions seen in all ten test animals in the 60 % (w/w) concentration were more marked than in the controls and were considered to indicate a positive sensitisation response.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The results of this test indicate that HEMA-PC is sensitising to the skin.
- Executive summary:
A skin sensitising study was conducted on HEMA-PC using OECD Guideline 406 (Skin Sensitisation) and EU Method B.6 (Skin Sensitisation). The results of this test indicate that HEMA-PC is sensitising to the skin.
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