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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 September 2007 to 01 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Commission Directive 2004/73/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Date of inspection: 21 August 2007 Date of Signature: 15 October 2007)
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
- Details on test material:
- - Name of test material (as cited in study report): MPC
- Substance type: White powder
- Physical state: Solid
- Lot/batch No.: 270103 (received on 14 September 2007)
- Storage condition of test material: Approximately 4ºC in the dark until 26 October 2007, thereafter approximately 4ºC in the dark over silica gel.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, United Kingdom.
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet ad libitum throughout the study.
- Water (e.g. ad libitum): Mains drinking water ad libitum throughout the study.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eyes in the exposured animals were used as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, weighed approximately 91 mg. - Duration of treatment / exposure:
- Up to 72 hours.
- Observation period (in vivo):
- Up to 72 hours.
- Number of animals or in vitro replicates:
- 3 (one for the assessment of the initial pain reaction, two for the assessment of ocular damage/irritation).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : No.
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the grading in the test guideline. The result was classified according to EU classification system.
TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope.
OTHERS
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1 in 'any other information on materials and methods incl. tables'. After consideration of the ocular responses produced in the first animal, two additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, United Kingdom) was instilled into both eyes of these animals 1 to 2 minutes before the treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- 66659 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48-h
- Remarks on result:
- other: max score of 1 observed at 1-h and 24-h.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- 66707 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48-h
- Remarks on result:
- other: max score of 1 observed at 1-h and 24-h.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- 66715 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48-h
- Remarks on result:
- other: max score of 1 observed at 1-h and 24-h.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 66659 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: max score of 1 was observed at 1-h, fully reversible within 24-h.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 66707 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: max score of 1 was observed at 1-h, fully reversible within 24-h.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 66715 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: max score of 1 was observed at 1-h, fully reversible within 24-h.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 66659 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 66707 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 66715 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 66659 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 66707 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 66715 Male
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 hour observation. However, changes were fully reversible within 2 days. No corneal or iridal effects were noted. See Table 2 for the details.
- Other effects:
- Not reported.
Any other information on results incl. tables
Table 2 Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex | 66659 Male | 66707 Male | 66715 Male | |||||||||
IPR = 3 | IPR = 0 + | IPR = 0 + | ||||||||||
Time After Treatment | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours |
CORNEA | ||||||||||||
Degree of Opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Area of Cornea Involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVA | ||||||||||||
Redness | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
Chemosis | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Discharge | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
IPR= Initial pain reaction
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material following a single application to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC
Initial considerations. In the absence of skin irritation data, a REET was performed prior to the in vivo test (see a brief summary in 'any other information on materials and methods incl. tables'). The results of the REET indicated that the test material was unlikely to cause severe occular irritancy.
Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour aboservation.
Conclusion. The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
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