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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

Endpoint summary
Administrative data
Description of key information
Skin irritation: Three in vivo studies are available for skin irritation. The study reported by Bullock (1972) as the key study is conducted according to modern guidelines and performed in a GLP accredited facility. The results of this study are sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The additional studies (Birch, 1972 and Birch, 1973) are provided to support this conclusion.
Eye irritation: Two in vivo studies are available for eye irritation. The key study (Freeman C, 1987) is conducted to a protocol similar to modern day guidelines and was performed in a GLP accredited facility. Despite only having assessed the eyes of two animals, the results are deemed sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The supporting study (Birch MD, 1973) supports the use of the key study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were examined at 24 and 72 hours only. No data reported on reversibility of effects. Study uses intact and abraded skin. No controls were included in the study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were examined at 24 and 72 hours only. No data reported on reversibility of effects. Study uses intact and abraded skin. No controls were included in the study.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Preparation of test site:
- other: Shaved, abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g
VEHICLE
Used as received. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Up to 72 hours
- Number of animals:
- 6, 3 males and 3 females.
- Details on study design:
- TEST SITE
- Type of wrap if used: Rubber (occlusive)
REMOVAL OF TEST SUBSTANCE
No data
SCORING SYSTEM:
The Draize dermal method of testing primary irritant substance as described in the Code of Federal Refulations under the Federal Hazardous Substances Labelling Act, Part 191.11, Chapter 1, Title 21.
Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; indexes from 2 to 5 are moderate irritants and those with scores above 5 are considered severe or primary irritants. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The primary dermal irritation index is calculated by the following:
Total ÷ 4 = Primary dermal irritation index - Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 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).
Reference
Table 1: Results for Disodium phosphate
Exposure time Hours |
Rabbit No. |
Mean |
||||||
|
8M |
15M |
16M |
32F |
33F |
34F |
||
|
Score |
Score |
Score |
Score |
Score |
Score |
||
Erythema |
||||||||
24 |
Intact |
1 |
1 |
0 |
0 |
0 |
0 |
0.33 |
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
24 |
Abraded |
3 |
4 |
3 |
3 |
3 |
4 |
3.33 |
72 |
Abraded |
3 |
3 |
3 |
3 |
3 |
2 |
2.83 |
Subtotal |
6.49 |
|||||||
Oedema |
||||||||
24 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
24 |
Abraded |
1 |
2 |
1 |
1 |
1 |
1 |
1.17 |
72 |
Abraded |
2 |
1 |
2 |
1 |
1 |
1 |
1.33 |
Subtotal |
2.50 |
|||||||
Total score |
8.99 |
|||||||
(Total/4) Primary Irritation Index |
2.25 |
|||||||
Result |
Moderate Irritant |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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).
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Three in vivo studies are available for skin irritation. The study reported by Bullock (1972) is selected as the key study as it is conducted according to guidelines similar to current test methods.
Justification for selection of eye irritation endpoint:
Two in vivo studies are available for eye irritation. The key study (Freeman C, 1987) is conducted to a protocol similar to modern day guidelines and was performed in a GLP accredited facility.
Justification for classification or non-classification
The data available for skin and eye irritation of disodium hydrogenorthophosphate conclude that no classification is required according to Regulation (EC) No. 1272/2008 (EU CLP). It is not considered scientifically justified on ethical grounds to repeat in vivo studies for these endpoints as the data provided is sufficient in accordance with REACH Annex XI.
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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