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EC number: 232-221-5 | CAS number: 7790-76-3
- 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: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 02 January 2013 and 10 January 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no minor deviations from standard test guidelines and no minor methodological deficiencies. This study is conducted according to an appropriate validated in vitro 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. 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).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
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: 10 July 2012; Date of Signature on GLP certificate: 30 November 2012
Test material
- Reference substance name:
- Dicalcium pyrophosphate
- EC Number:
- 232-221-5
- EC Name:
- Dicalcium pyrophosphate
- Cas Number:
- 7790-76-3
- Molecular formula:
- Ca2O7P2
- IUPAC Name:
- dicalcium (phosphonatooxy)phosphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification : IP 26: Dicalcium pyrophosphate
CAS number: 7790-76-3
Description: white powder
Batch number: MV3603
Date received: 24 September 2012
Expiry date: 03 May 2014
Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White (Hsdlf:NZW)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Leicestershire, UK.
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: 2.61 or 2.93 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 Laboratories UK Ltd, 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): 100 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.
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
INTERPRETATION OF RESULTS
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) * 2
Score for iris = D * 5
Score for cornea = (E * F) * 5
Using the numerical data obtained a modified version of the system described by Kay JH and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281-289 (see below) was used to classify the ocular irritancy potential of the test item. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test item.
If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.
The results were also interpreted according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 72824 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 72839 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 72824 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.25
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 72839 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.25
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Remarks:
- 72824 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Remarks:
- 72839 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 72824 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 72839 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2.
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes one hour after treatment.
Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one hour after treatment. Minimal conjunctival irritation noted in both treated eyes at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation. - Other effects:
- Individual bodyweights and bodyweight changes are given in Table 3.
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 |
72824 Male |
72839 Male |
||||||
IPR = 1 |
IPR = 2 |
|||||||
Time After Treatment |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA |
|
|
|
|
|
|
|
|
Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
||||
Redness |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
Chemosis |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Discharge |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
IPR = Initial pain reaction
Table 2. Individual bodyweights and bodyweight changes
Rabbit number and sex |
Individual bodyweight (kg) |
Bodyweight change (kg) |
|
72824 Male |
Day 0 |
Day 3 |
0.07 |
2.93 |
3.00 |
||
72839 Male |
Day 0 |
Day 21 |
0.07 |
2.61 |
2.68 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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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