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EC number: 233-279-4 | CAS number: 10102-90-6
- 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: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2013-01-14 to 2013-02-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diphosphoric acid, copper salt
- EC Number:
- 233-279-4
- EC Name:
- Diphosphoric acid, copper salt
- Cas Number:
- 10102-90-6
- Molecular formula:
- Cu.xH4O7P2
- IUPAC Name:
- diphosphoric acid, copper salt
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Sponsor's identification: IP 37: Copper (II)-pyrophosphate
Description: pale blue powder
Batch number: MV500
Purity: >80% (based on Cu content >34%)
Impurities: <18% water, <2% free orthophosphate, pyrophosphate
Date received: 24 September 2012
Expiry date: 12 February 2015
Storage conditions: room temperature in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.48 or 2.59 kg
- Housing: animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test item (weighing approximately 83 mg as measured by gently compacting the required volume into an adapted syringe). - Duration of treatment / exposure:
- Animals were observed for 7 days post-dosing.
- Observation period (in vivo):
- 7 Days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
The test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released.
After consideration of the ocular responses produced in the first treated animal, a second animal was treated. In order to minimise pain on application of the test item, one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Bausch & Lomb, Surrey, UK) was instilled into both eyes of the second animal 1 to 2 minutes before treatment.
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.
ADDITIONAL OBSERVATIONS:
Any clinical signs of toxicity, if present, were also recorded.
An additional observation was made on Day 7 to assess the reversibility of the ocular effects.
Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effects noted
- Remarks on result:
- other: IPR = 3
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effects noted
- Remarks on result:
- other: IPR = 0 (anaesthetic administered)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- (conjunctivae)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- (conjunctivae)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Individual scores for ocular irritation are given in Table 1. The individual and mean scores as required for EU and GHS classification and labelling are presented in Table 2.
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes one hour after treatment and at the 24 and 48-Hour observations and in one treated eye at the 72-Hour observation.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24 and 48-Hour observations. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye 72-Hour observation.
Both treated eyes appeared normal at the 7-Day observation. - Other effects:
- Individual bodyweights and bodyweight change 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 Scores for Ocular Irritation
Rabbit number and Sex |
72877 Male
|
72918 Male |
||||||||
IPR = 3 |
IPR = 0+ |
|||||||||
Time after treatment |
1 Hrs |
24 Hrs |
48 Hrs |
72 Hrs |
7 days |
1 Hrs |
24 Hrs |
48 Hrs |
72 Hrs |
7 days |
Cornea Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of cornea involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
Conjuctivae Redness |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
0 |
Chemosis |
3 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
Discharge |
1 |
2 |
2 |
0 |
0 |
3 |
1 |
1 |
1 |
0 |
IPR = Initial pain reaction
+ = One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment
Table 2. Individual and Mean Scores for Cornea, Iris and Conjunctivae
Rabbit number and sex |
Time after treatment |
Corneal opacity |
Iridial inflammation |
Conjuntival redness |
Conjunctival chemosis |
72877 Male
|
24 hours 48 hours 72 hours |
0 0 0 |
1 1 0 |
2 2 2 |
2 2 1 |
Mean: |
0.0 |
0.7 |
2.0 |
1.7 |
|
72918 Male |
24 hours 48 hours 72 hours |
0 0 0 |
1 1 1 |
2 2 2 |
2 2 2 |
Mean: |
0.0 |
1.0 |
2.0 |
2.0 |
Table 3. Individual Bodyweights and Bodyweight Change
Rabbit number and sex |
Individual bodyweight (kg) |
Bodyweight change (kg) |
|
Day 0 |
Day 7 |
||
72877 Male |
2.48 |
2.60 |
0.12 |
72918 Male |
2.59 |
2.75 |
0.16 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item was classified as irritating to eyes (Category 2) according to Regulation (EC) No 1272/2008.
- Executive summary:
The test item was classified as irritating to eyes (Category 2) according to Regulation (EC) No 1272/2008. It is reasonable to assume that the signal word “Warning” and the Hazard Statement “H319: Causes serious eye irritation” are therefore required. This study is considered to be adequate and reliable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and as a key study in accordance with Regulation (EC) No. 1907/2006 (REACH).
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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