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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
Eye irritation
Administrative data
- 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
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:
- 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
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 2012
Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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).
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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