Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 26 June 2012 and 2 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of GLP inspection: 19-21 July 2011 Date of Signature on GLP certificate: 31 August 2011
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Trisodium hydrogen diphosphate
- EC Number:
- 238-735-6
- EC Name:
- Trisodium hydrogen diphosphate
- Cas Number:
- 14691-80-6
- Molecular formula:
- H1O7P2Na3
- IUPAC Name:
- trisodium hydrogen (phosphonooxy)phosphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification: trisodium hydrogen diphosphate
Description: white powder
Batch number: 147/12
Purity: 95%
Date received: 07 March 2012
Expiry date: 01 February 2014
Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
- Fasting period before study: overnight fast immediately before dosing
- Housing: The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet supplied by Harlan Laboratories UK Limited, Bicester, Oxon, UK was allowed ad libitum throughout the study.
- Water (e.g. ad libitum): free access to mains drinking water.
- Acclimation period: at least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 1 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: For the purpose of the study the test material was freshly prepared, as required, as a suspension in distilled water to give a dose levels of 300 mg/kg and 2000 mg/kg bodyweight.
- Amount of vehicle: Not stated
- Justification for choice of vehicle: Distilled water was the preferred vehicle of the test method.
- Lot/batch no.: Not applicable
- Purity: Not applicable
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION: Not applicable
CLASS METHOD: Not applicable
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose. - Doses:
- Dosing regimen:
A single animal was treated with the starting dose of 300 mg/kg bw. In this absence of toxicity on this animal an additional animal was treated with 2000 mg/kg bw. As this animal exhibited no toxicity an additional 4 animals were treated with 2000 mg/kg be of the test material (a total of 5 animals were treated with 2000 mg/kg bw). Due to mortality and signs of systemic toxicity in the animals tested at 2000 mg/kg bw an additional group of 4 animals were treated with 300 mg/kg bw (a total of 5 animals were treated with 300 mg/kg bw). - No. of animals per sex per dose:
- 5 females at 2000 mg/kg
5 females at 300 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed:
Yes
- Other examinations performed:
Clinical signs, body weight.
Results and discussion
- Preliminary study:
- A sighting test at a dose level of 300 mg/kg was performed and a sighting test at a dose level of 2000 mg/kg was performed.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence limits not given in study report.
- Mortality:
- Dose Level - 2000 mg/kg: Two animals were found dead one or two days after dosing.
Dose Level - 300 mg/kg: There were no deaths. - Clinical signs:
- other: Dose level - 2000mg/kg: Signs of systemic toxicity noted were hunched posture, pilo-erection, ptosis, lethargy and ataxia. Surviving animals appeared normal one, five or six days after dosing. Dose level - 300mg/kg: No signs of systemic toxicity were not
- Gross pathology:
- Dose level - 2000mg/kg: Abnormalities noted at necropsy of animals that died during the study were dark liver, dark spleen, dark kidneys and haemorrhagic gastric mucosa. A raised limiting ridge of the stomach and pale gastric mucosa were noted at necropsy of one animal that was killed at the end of the study. No abnormalities were noted at necropsy of the remaining animals that were killed at the end of the study.
Dose level - 300mg/kg: No abnormalities were noted at necropsy. - Other findings:
- - Organ weights: Not recorded
- Histopathology: Not recorded
- Potential target organs: Not recorded
- Other observations: None
Any other information on results incl. tables
Table 1. Individual Clinical Observations and Mortality Data -2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
0 |
0 |
0 |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
HP |
H |
H |
HP |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
HAPPtL |
X |
|
|
|
|
|
|
|
|
|
|
|
|||
3-3 Female |
0 |
0 |
0 |
HLP |
HAP |
X |
|
|
|
|
|
|
|
|
|
|
|
0 = No signs of systemic toxicity
H = Hunched posture
P = Pilo-erection
Pt = Ptosis
L = Lethargy
A = Ataxia
X
= Animal dead
Table 2. Individual Bodyweights and Bodyweight Changes -2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight (g) |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
2-0 Female |
162 |
179 |
187 |
|
17 |
8 |
3-0 Female |
186 |
202 |
217 |
16 |
15 |
||
3-1 Female |
180 |
174 |
213 |
- 6 |
39 |
||
3-2 Female |
165 |
- |
- |
160 |
- |
- |
|
3-3 Female |
166 |
- |
- |
153 |
- |
- |
Table 3. Individual Necropsy Findings -2000 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
||||
2000 |
2-0 Female |
Killed Day 14 |
Stomach: raised limiting ridge Gastric mucosa: pale |
||||
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|||||
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|||||
3-2 Female |
Animal found dead Day 1 |
Liver: dark Spleen: dark Kidneys: dark Gastric mucosa: haemorrhagic |
|||||
3-3 Female |
Animal found dead Day 2 |
Liver: dark Spleen: dark Kidneys: dark Gastric mucosa: haemorrhagic |
Table 4. Individual Clinical Observations and Mortality Data - 300mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 5. Individual Bodyweights and Bodyweight Changes - 300mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
2-0 Female |
162 |
187 |
202 |
25 |
15 |
3-0 Female |
182 |
199 |
216 |
17 |
17 |
|
3-1 Female |
188 |
197 |
220 |
9 |
23 |
|
3-2 Female |
183 |
199 |
214 |
16 |
15 |
|
3-3 Female |
189 |
214 |
230 |
25 |
16 |
Table 6. Individual Necropsy Findings - 300mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight (EU CLP - Category 4).
This study is considered to be reliable and acceptable for use as a key study in accordance with Regulation (EC) No. 1907/2006 (REACH) and for the purposes of classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). - Executive summary:
.
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.
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.