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EC number: 231-987-8 | CAS number: 7783-28-0
- 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
An in vtro eye irritation showed no irritation. No reliable in vivo irritation data on diammonium hydrogenorthophosphate were available. Based on reliable in vivo studies with ammonium dihydrogenorthophosphate showing no or minimal irritation, it is concluded that that diammonium hydrogenorthophosphate is not irritating to skin and eyes. The read-across rationale can be found in the category approach document attached in Section 13 of IUCLID and is fully incorporated in the CSR (see Appendix A).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, near-guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 h exposure under occlusive conditions
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80% - Duration of treatment / exposure:
- 24 h
- Observation period:
- 9 days
- Number of animals:
- 3 male and 3 female
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
Reference
time |
animal 1 |
animal 2 |
animal 3 |
animal 4 |
animal 5 |
animal 6 |
|
erythema |
24 h |
1 |
1 |
0 |
0 |
0 |
1 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 d |
0 |
0 |
0 |
0 |
0 |
0 |
|
edema |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 d |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 April 2010 to 08 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea
- Concentration (if solution): 20% (w/w)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/w) Imidazole - Duration of treatment / exposure:
- 240 minuten
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean after 240 min
- Value:
- 13
- Remarks on result:
- other: not severe irritant or corrosive
- Other effects / acceptance of results:
- Score was 13 after 240 minutes, which is below 55.1 and thus substance is not severe irritant or corrosive.
- Interpretation of results:
- other: not severe irritant or corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The positive and negative controls were within the historical control data.
The mean in vitro irritancy score was 13 after 240 minutes of treatment with Diammonium hydrogenorthophosphate. Since the mean in vitro irritancy score was below 55.1 after 240 minutes treatment Diammonium hydrogenorthophosphate is considered to be not severe irritant or corrosive.
Finally, it is concluded that this test is valid and that Diammonium hydrogenorthophosphate is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
No reliable studies on diammonium hydrogenorthophosphate are present. However, in a reliable skin irriation study performed comparable to OECD 404 guideline, ammonium dihydrogenorthophosphate does show some effects on the erythema, which are minimal and fully reversible within 72 hours.
Eye irritation
An in vitro Bovine Corneal Opacity and Permeability test (OECD 437 guideline) showed that diammonium hydrogenorthophosphate is a not an irritant under the test conditions. In addition, no reliable in vivo studies on diammonium hydrogenorthophosphate are present. However, in a reliable eye irriation study performed comparable to OECD 405 guideline, ammonium dihydrogenorthophosphate does not show any effects on the cornea and iris, but does show some limited effects on the conjunctiva (score 1 out of 3). These were decreasing in time, however not fully reversible within 72 hours (in 2 out of 6 animals). Because reversibility of the findings is expected due to the trend obvious in the individual data, the substance is considered a non-irritant.
Justification for selection of skin irritation / corrosion endpoint:
One in vivo study on the read-across study ammonium dihydrogenorthophosphate is available. Since the study was performed with a substance analogue and the data are read across, the Klimisch score is 2.
Justification for selection of eye irritation endpoint:
One in vitro study on the substance is available.
Justification for classification or non-classification
Based on the available data, diammonium hydrogenorthophosphate does not have to be classified according to Directive 67/548/EC and the CLP Regulation for skin and eye irritation.
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