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EC number: 238-735-6 | CAS number: 14691-80-6
- 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: In accordance with the testing strategy detailed in Annex VIII, column 1 of Regulation (EC) No. 1907/2006 the assessment of the endpoint ‘skin irritation or skin corrosion’ has been performed following the consecutive steps detailed in the Regulation. As such an in vitro skin corrosion study has been performed. This study is not considered as the key study because it is not sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and is therefore submitted as supporting data. The key study (Lowe C, 2013) is conducted according to an appropriate validated in vivo guideline and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint and supersedes the study performed in vitro (warren 2012). In addition, the data is considered to be adequate and reliable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).Eye irritation: In accordance with the original testing strategy detailed in Annex VIII, column 1 of Regulation (EC) No. 1907/2006 (REACH) an ex vivo study was performed prior to conducting an in vivo study. This study was not considered as the key study because at the time of performing the study it was not considered to be suitable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The key study (Bradshaw J, 2010) is conducted according to an appropriate guideline and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy the regulatory requirement as a key study for this endpoint.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc on October 3, 2012
- Age at study initiation: Young adult
- Weight at study initiation:
- Housing: The animals were signly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent 'Guide for the care and use of laboratory animals'. Litter paper was placed beneath the cage and was changed at least 3 times a week.
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet # 2031. A designated amount of the diet was available to each rabbit (150 g/day)
- Water (e.g. ad libitum): Filtered tap water was available ad libitum.
There were no known contaminants reasonable expected to be found in the food or water at levels which would interfere with the results of this study. Analysis of food and water were conducted regularly.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 41-69%
- Air changes (per hr): 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.77 g of the test mixture.
- Concentration (if solution): 65% w/w in water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Up to 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6cm2 intact dose site
- Type of wrap if used: semi-occlusive
The test item was placed on a 1 inch by 1 inch 4-ply gauze pad. The pad and entire trunk of each animal was then wrapped with semi-occlusive 3 inch micropore tape to avoid dislocation of the pad.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was gently clensed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system. - Irritation parameter:
- erythema score
- Basis:
- other: All 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects noted
- Irritation parameter:
- edema score
- Basis:
- other: all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects noted
- Other effects:
- All animals appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation and adverse pharmacologic effects or abnormal behaviour.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, trisodium hydrogen diphosphate is classified as non-irritating to the skin.
Reference
Table 1: Erythema/Edema
Animal No. |
Sex |
Time after patch removal |
|||
30-60 mins |
24 hrs |
48 hrs |
72 hrs |
||
3501 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
3502 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
3503 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
Total |
0/0 |
0/0 |
0/0 |
0/0 |
|
Mean |
0/0 |
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, other
- Remarks:
- In vivo: 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:
- The study was performed between 30 July 2012 and 04 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of GLP inspection: Date of Signature on GLP certificate: 26/11/2009
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: 2.37 or 2.69 kg
- Housing: The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet (e.g. ad libitum): ad libitum (2030C Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK)
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES:
From: day 1 To:day 3 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml (96 mg) of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.
- Concentration (if solution): Undiluted and used as supplied
VEHICLE
- Amount(s) applied (volume or weight with unit):Not applicable
- Concentration (if solution):Not applicable
- Lot/batch no. (if required):Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- Up to 21 days (test item was not removed from the eyes).
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects.
- Number of animals or in vitro replicates:
- 2 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, one additional animals was treated).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 72293 Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 72394 Male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 72293 Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effect observed
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 72394 Male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- 72293 Male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- 72394 Male
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Haemorrhage on the lower and nictating conjunctival membranes was observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 72293 Male
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 72394 Male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Individual scores for ocular irritation are given in Table 1.
Scattered or diffuse corneal opacity was noted in one treated eye one hour after treatment and at the 24, 48, 72-Hour, 7, 14 and 21-Day observations.
Iridial inflammation was noted in one treated eye one hour after treatment and at the 24, 48, 72-Hour and 7-Day observations.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment. Severe conjunctival irritation was noted in one treated eye and moderate conjunctival irritation was noted in the other treated eye at the 24-Hour observation. Moderate conjunctival irritation was noted in both treated eyes at the 48 and 72-Hour observations. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye at the 7-day observation. Minimal conjuctival irritation was noted in one treated eye at the 14-day observation.
Petechial haemorrhage of the nictitating and lower conjunctival membranes was noted in one treated eye one hour after treatment and at the 24, 48 and 72-Hour observations. A small area of haemorrhage, approximately 3 mm x 3 mm in size, on the lower eyelid was noted in this treated eye at the 7-Day observation. A small dark brown/black coloured scab, possibly due to rabbit scratching, was noted on the lower eyelid of this animal at the 14-Day observation. One treated eye appeared normal at the 14-Day observation.
The persistence of reactions in one treated eye at the 21-Day observation was considered to be indicative of irreversible ocular damage. - Other effects:
- BODYWEIGHT: Individual bodyweights and bodyweight changes are given in Table 2.
Both animals showed expected gain in bodyweight during the study. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item produced irreversible ocular damage and was considered to be corrosive to the rabbit eye and classified as Irreversible effects on the eye (Category 1) according to Regulation (EC) No. 1272/2008 (EU CLP).
This study is conducted according to the appropriate guidelines (OECD 405) and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for REACH (Regulation (EC) No.1907/2006) as a key study for this endpoint. Study is sufficient for classification and labelling purposes, in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Reference
Table 1. Individual Score and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
72293 Male |
72394 Male |
|||||||||||
IPR= 3 |
IPR = 0+ |
||||||||||||
Time After Treatment |
1 |
24 |
48 |
72 |
7 |
14 Days |
1 |
24 |
48 |
72 |
1 Day |
14 Days |
21 Days |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
|
Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
4 |
4 |
3 |
2 |
1 |
1 |
IRIS |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|||||
Redness |
2 |
2 |
2 |
2 |
1 |
0 |
3Pt |
3Pt |
3Pt |
3Pt |
2H |
2¤ |
1 |
Chemosis |
2 |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
2 |
2 |
1 |
0 |
Discharge |
2 |
1 |
1 |
1 |
0 |
0 |
2 |
3 |
2 |
2 |
1 |
0 |
0 |
IPR= Initial pain reaction
+ = One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment
Pt = Petechial haemorrhage on the nictitating and lower conjunctival membranes
H = Small area of haemorrhage, approximately 3 mm x 3 mm in size, on lower eyelid
¤ = Small dark brown/black coloured scab on lower eyelid , possibly due to rabbit scratching
Table 2. Individual bodyweights and bodyweight changes
Rabbit number and sex |
Individual bodyweight (kg) |
Bodyweight change (kg) |
|
72293 Male |
Day 0 |
Day 14 |
0.24 |
2.69 |
2.93 |
||
72394 Male |
Day 0 |
Day 21 |
0.43 |
2.37 |
2.80 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for selection of skin irritation / corrosion endpoint:
One key study available. This study is conducted according to the
appropriate guidelines (OECD 404) and under the conditions of GLP and
therefore the study is considered to be acceptable and to adequately
satisfy both the guideline requirement and the regulatory requirement
for REACH (Regulation (EC) No.1907/2006) as a key study for this
endpoint. Study is sufficient for classification and labelling purposes,
in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and
contradictory in vitro data are disregarded on the basis that in vivo
data supercedes in vitro data.
Justification for selection of eye irritation endpoint:
One key study available. This study is conducted according to the
appropriate guidelines (OECD 405) and under the conditions of GLP and
therefore the study is considered to be acceptable and to adequately
satisfy both the guideline requirement and the regulatory requirement
for REACH (Regulation (EC) No.1907/2006) as a key study for this
endpoint. Study is sufficient for classification and labelling purposes,
in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Justification for classification or non-classification
Skin irritation: The data available to assess the skin irritation potential of trisodium hydrogen diphosphate concludes that the substance is not classified as skin irritant in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and on the basis of the in vivo data. Contradictory in vitro data has been disregarded.
Eye irritation: The data available to assess the eye irritation potential of trisodium hydrogen diphosphate concludes that the substance is classified as Category 1 corrosive to eyes on the basis of irreversible damage noted at the end of the study. Classification is derived in accordance with Regulation (EC) No. 1272/2008 (EU CLP). It is not considered scientifically justified on ethical grounds to repeat in vivo studies for this endpoint as the data provided is sufficient.
Respiratory irritation: There are no data available (workplace observations or studies) to suggest that trisodium hydrogen diphosphate is a respiratory irritant.
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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