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Diss Factsheets
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EC number: - | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Originally, the test was carried out for the purpose of another regulation- registration in the US according to TSCA - US EPA OPPTS 870.240 Acute Eye irritation [EPA712-C-98-195]
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 3 - January 6, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Originally, the tst was carried out for the purpose of another rgulation- Registration in the US according to TSCA US EPA OPPTS 870.2400 Acute eye irritation.
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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12- NOUSAN-8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
- Cas Number:
- 2230512-72-6
- Molecular formula:
- C7H17O3P
- IUPAC Name:
- Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate
- Test material form:
- liquid
- Details on test material:
- R&D level
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Housing: The animals were singly housed in suspended stainless steel caging which
conforms to the size recommendations in the most recent Guide for the Care and Use
of Laboratory Animals (Natl. Res. Council, 20 11). Enrichment (e.g., toy) was placed
in each cage. Litter paper was placed beneath the cage and was changed at least three
times per week.
Animal Room Temperature and Relative Humidity Ranges: 20-23"C and 42-47%,
respectively.
Animal Room Air Changes/Hour: 13. Airflow measurements are evaluated regularly
and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 6 days
Food: Envigo Teklad Global High Fiber Rabbit Diet® #2031. A designated amount
of the diet (approximately ISO grams/day) and a Premium Timothy Cube™ (Ontario
Dehy Inc.) were available to each rabbit.
Water: Filtered tap water was supplied ad libitum.
Contaminants: There were no known contaminants reasonably expected to be found
in the food or water at levels which would have interfered with the results of this
study. Analyses of the food and water are conducted regularly and the records are
kept on file at Product Safety Labs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of test substance
- Duration of treatment / exposure:
- up to 72 hours post instilation
- Observation period (in vivo):
- 1, 24, 48, 72 hours (Draize method)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PROCEDURE
A. Preparation and Selection of Animals
Prior to test initiation, both eyes of a group of animals were examined using a white I ight source
and a fluorescein dye procedure. One drop of ophthalmic fluorescein sodium dye was instilled
into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) after
instillation of the fluoresccin and then evaluated for corneal damage using an ultraviolet light
Source. Prior to test substance instillation, the eyes were re-examined and scored for
abnonnalities according to the "Scale for Scoring Ocular Lesions" (Draize et aI., 1944; see Table
4). Three healthy, naive animals (not previously tested) without pre-existing ocular irritation
were selected for test.
A systemic analgesic (Buprenorphine SR®) was administered to relieve potential discomfort
associated with eye irritation which provides therapeutic relief for periods of up to 76 hours.
Prior to test substance instillation, 0.1 mg/kg of body weight of the analgesic was administered to
the animals and at appropriate intervals to maintain therapeutic blood levels.
B. Preparation of Test Substance
The test substance was instilled as received and mixed well prior to use.
The pH was determined for the test substance prior to the instillation and was within a pH range
of 2 and 11.5, therefore testing proceeded. The procedure used and the results are retained in the
raw data.
C. Instillation
Prior to instillation, 1-2 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmic
Solution USP, 0.5%) were placed into both the treated and control eye of each animal. One-tenth
of a milliliter of the test substance was then instilled into the conjunctival sac of the right eye of
each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then
gently held together for about one second before releasing to minimize loss of the test substance.
The other eye of each rabbit remained untreated with the test substance and served as a control.
The rabbits were then returned to their designated cages.
D. Ocular Scoring
Ocular irritation was evaluated using a white light source in accordance with the Draize method
of scoring (Draize et aI., 1944; see Table 4) at I, 24, 48, and 72 hours post-instillation. The
fluorescein dye evaluation procedure described in Section 5.A. was used in the treated eye at 24
hours to verity the absence of corneal damage. Individual scores were recorded for each animal.
In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were
noted. The average score for all rabbits at each scoring period was calculated to aid in data
interpretation.
E. Classification of Eye Scores
The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all
rabbits was used to classity the test substance by the system of Kay and Calandra (Kay &
Calandra, 1962).
F. Cage-Side Observations
The animals were observed for signs of gross toxicity and behavioral changes at least once daily
during the test period.
G. Body Weights
Individual weights of animals were recorded shortly before instillation of the test substance
(initial) and at the completion of testing (tenninal). Additional body weights were taken to
determine the appropriate amount of analgesic. These additional body weights were recorded in
the raw data but are not reported.
H. Study Termination
Once testing was complete, the animals were released for euthanasia and humanely euthanized.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 80
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 10
- Reversibility:
- other:
- Remarks:
- no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: minimal irritation (Kay and Calandra, 1962) see attached classification of eye score table
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- >= 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- mildly irritation (Kay and Calandra, 1962) see attached classification of eye score table
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- >= 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: minimaly irritation (Kay and Calandra, 1962) see attached classification of eye score table
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- >= 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- >= 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mildly irritation (Kay and Calandra, 1962) see attached classification of eye score table
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: minimal irritation (Kay and Calandra, 1962) see attached classification of eye score table
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour after test substance instillation, minimal conjunctivitis was noted for all treated eyes.
There was no corneal opacity or iritis observed in any treated eye during this study. The overall
incidence and severity of irritation decreased with time. All animals were free of ocular irritation
by 72 hours (study termination). see attached table 3
Any other information on results incl. tables
All animals appeared active and healthy and gained body weight during the study. see attached table 2.
Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse clinical effects,
or abnormal behavior. Individual cage side observations in the attached table 1.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not subject to classification under GHS
- Conclusions:
- Under the conditions of this study, E17-194T is considered as mildly irritating to the eye
- Executive summary:
A primary eye irritation test was conducted with rabbits to determine the potential for
E17-194T to produce irritation from a single instillation via the ocular route. Under the
conditions of this study, the test substance is classified as mildly irritating to the eye.
One-tenth of a milliliter of the test substance was instilled into the right eye of three healthy
rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated
by the Draize method of scoring (Draize, Woodard, & Calvery, 1944; see Table 4).
One hour after test substance instillation, minimal conjunctivitis was noted for all treated eyes.
There was no corneal opacity or iritis observed in any treated eye during this study. The overall
incidence and severity of irritation decreased with time. All animals were free of ocular irritation
by 72 hours (study termination).
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.