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EC number: 231-448-7 | CAS number: 7558-79-4
- 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:
- Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-08-11 to 1986-08-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- eyes were irrigated after 20 - 30 sec, rather than after 1 h recommended in the guideline.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium hydrogenorthophosphate
- EC Number:
- 231-448-7
- EC Name:
- Disodium hydrogenorthophosphate
- Cas Number:
- 7558-79-4
- Molecular formula:
- H3O4P.2Na
- IUPAC Name:
- disodium hydrogen phosphate
- Test material form:
- other: granular solid
- Details on test material:
- - Name of test material: disodium phosphate
- Molecular formula: Na2HPO4
- Physical state: white granules
- Analytical purity: > 97% based on H2O content
- Stability under test conditions: stable indefinitely
- Storage condition of test material: room temperature
- Other: Reference number: 280B 2037S
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: 2.43 - 2.71 kg
- Weight at study initiation: young adult
- Housing: individually housed in stainless steel rabbit cages and DACB cageboard bedding was used in the litter pans.
- Diet: ad libitum
- Water:ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 - 75 ºC
- Humidity (%): 53 - 60 %
- Photoperiod: 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of the rabbits were used for treatment, the left eyes served as controls.
- Amount / concentration applied:
- 0.1 g per test eye
- Duration of treatment / exposure:
- The eyes of two of the rabbits remained unwashed and the eyes of the remaining two rabbits were gently washed approximately 20 - 30 sec after treatment.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 4 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: gently washed with 100 mL of tap water . The rate of application of the tap water was approximately 100 mL/min.
- Time after start of exposure: 20 - 30 sec
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: after the 24 h examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- One h after dosing, mild conjuncitvitis was observed in all eyes. At the 24 h scoring, both of the unwashed eyes had mild conjunctivitis and one of the washed eyes had a slight discharge. Within 48 h of dosing, washed eyes had recovered; both unwashed eyes exhibited slight conjunctivitis which had resolved by the 72 h scoring. Washing the eyes with tap water shortly after exposure decreased both the severity and the duration of the irritation observed.
- Other effects:
- The mean body weight of the animals was 2.59 ± 0.120 kg on the day prior to dosing. All animals remained healthy throughout the study.
Any other information on results incl. tables
Pretest eye examination
Animal No. |
Exam method |
Right eye |
Left eye |
Body weight (kg) |
B5490M |
Penlight |
N |
N |
2.57 |
|
Fluorescein |
N |
N |
|
B5538M |
Penlight |
N |
N |
2.64 |
|
Fluorescein |
N |
N |
|
B5492M |
Penlight |
N |
N |
2.43 |
|
Fluorescein |
N |
N |
|
B5477M |
Penlight |
N |
N |
2.71 |
|
Fluorescein |
N |
N |
|
Mean |
2.59 |
|||
± SD |
± 0.120 |
B - rabbit
N - normal
M - Male
Individual eye scores:
Animal No. |
Cornea |
Iris |
Conjunctiva |
Cornea |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
Stain/Area |
|
1 hour |
||||||
B5490M |
0 / 0 |
0 |
0 |
2 |
3 |
NA |
B5530M |
0 / 0 |
0 |
0 |
2 |
3 |
NA |
B5492M (w) |
0 / 0 |
0 |
0 |
1 |
3 |
NA |
B5477M (w) |
0 / 0 |
0 |
0 |
1 |
3 |
NA |
Primary eye irritation index – unwashed 10.0/110, washed 8.0/110 |
||||||
24 hour |
||||||
B5490M |
0 / 0 |
0 |
1 |
0 |
3 |
0 / 0 |
B5530M |
0 / 0 |
0 |
1 |
0 |
3 |
0 / 0 |
B5492M (w) |
0 / 0 |
0 |
0 |
0 |
1 |
0 / 0 |
B5477M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
0 / 0 |
Primary eye irritation index – unwashed 8.0/110, washed 1.0/110 |
||||||
48 hours |
||||||
B5490M |
0 / 0 |
0 |
1 |
0 |
2 |
NA |
B5530M |
0 / 0 |
0 |
1 |
0 |
1 |
NA |
B5492M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
NA |
B5477M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
NA |
Primary eye irritation index – unwashed 5.0/110, washed 0.0/110 |
||||||
72 hours |
||||||
B5490M |
0 / 0 |
0 |
0 |
0 |
0 |
NA |
B5530M |
0 / 0 |
0 |
0 |
0 |
0 |
NA |
B5492M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
NA |
B5477M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
NA |
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110 |
B - Rabbit
M - Male
(w) - Washed
NA - Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the author concludes that the test material is temporarily approximated to be minimally irritating to unwashed eyes and practically non-irritating to washed eyes.
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling when viewed in conjunction with the supporting data.
Disodium hydrogenorthophosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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