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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-10-07 to 2013-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- M 14-30 Copper-II-pyrophosphate
Batch number: 9000022795
Chemical name: diphosphoric acid, copper salt
CAS: 10102-90-6
EC: 233-279-4
Purity: >80% (based on Cu content >34%)
Impurities: <18% water, <2% free orthophosphate, pyrophosphate
Physical state: light blue solid powder
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Germany GmBH, Sulzfeld, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: between 190 and 250 g
- Fasting period before study: no diet over night prior to application and 3 hours after application
- Housing: signle-caged
- Diet (e.g. ad libitum): conventional laboratory diet (ad libitum with exception regarding fasting prior to and post test material application).
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: The animals were kept in their cages for at least 5 days prior to dosing to allow for acclimatisation to the laboratory conditions. The health of animals was controlled by veterinarians or other qualified staff members.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1ml/100 g bodyweight
DOSAGE PREPARATION: Test substance was suspended in distilled water.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit test at dose level 2000 mg/kg body weight (b. w.) was carried out since information about toxicity provided by sponsor has indicated that the test material is likely non-toxic at this dose level. - Doses:
- The test was performed in a step-wise manner with 2 test series (test and replicate test) at 2000 mg/kg bw.
- No. of animals per sex per dose:
- Each test group consisted of 3 female animals (6 in total).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observation parameters: spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature (evaluated by touch), muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex and back hair appearance.
- Frequency of observations and weighing: Animals were observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours and daily thereafter for a total of 14 days.
Individual weights of animals were determined shortly before the test substance was administered, and weekly thereafter. Weight changes were calculated and recorded. At the end of the test surviving animals were weighed and humanely killed.
- Necropsy of survivors performed: yes. All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal (included organs: oesophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- No animals showed any adverse clinical signs.
- Body weight:
- No adverse changes in bodyweight were recorded.
- Gross pathology:
- There were no abnormal macroscopic findings in any of organs after a 14-day observation period.
Any other information on results incl. tables
Table 1: Clinical observations from T0 to 4h; test group 1; dose level 2000 mg/kg
Observation from T0 to 4 h |
Test group 1 (2000 mg/kg) |
||
T1 |
T2 |
T3 |
|
Spontaneous activity |
NAD |
NAD |
NAD |
Preyer’s reflex (noise) |
NAD |
NAD |
NAD |
Respiratory rate |
NAD |
NAD |
NAD |
Convulsions |
NAD |
NAD |
NAD |
Tremors |
NAD |
NAD |
NAD |
Body temperature (evaluated by touch) |
NAD |
NAD |
NAD |
Muscle tone |
NAD |
NAD |
NAD |
Palpebral opening |
NAD |
NAD |
NAD |
Pupil appearance |
NAD |
NAD |
NAD |
Salivation |
NAD |
NAD |
NAD |
Lachrymation |
NAD |
NAD |
NAD |
Righting reflex |
NAD |
NAD |
NAD |
Back hair appearance |
NAD |
NAD |
NAD |
Other |
NAD |
NAD |
NAD |
MORTALITY |
0 |
0 |
0 |
Key:NAD = no abnormality detected
Table 2: Clinical observations from day 1 to day 14; test group 1; dose level 2000 mg/kg
Observation from day 1 – day 14 |
Test group 1 (2000 mg/kg) |
||
T1 |
T2 |
T3 |
|
Spontaneous activity |
NAD |
NAD |
NAD |
Preyer’s reflex (noise) |
NAD |
NAD |
NAD |
Respiratory rate |
NAD |
NAD |
NAD |
Convulsions |
NAD |
NAD |
NAD |
Tremors |
NAD |
NAD |
NAD |
Body temperature (evaluated by touch) |
NAD |
NAD |
NAD |
Muscle tone |
NAD |
NAD |
NAD |
Palpebral opening |
NAD |
NAD |
NAD |
Pupil appearance |
NAD |
NAD |
NAD |
Salivation |
NAD |
NAD |
NAD |
Lachrymation |
NAD |
NAD |
NAD |
Righting reflex |
NAD |
NAD |
NAD |
Back hair appearance |
NAD |
NAD |
NAD |
Other |
NAD |
NAD |
NAD |
MORTALITY |
0 |
0 |
0 |
Key: NAD = no abnormality detected
Table 3: Clinical observations from T0 to 4h; test group 2; retest dose level 2000 mg/kg
Observation from T0 to 4 h |
Test group 2 (2000 mg/kg) |
||
T4 |
T5 |
T6 |
|
Spontaneous activity |
NAD |
NAD |
NAD |
Preyer’s reflex (noise) |
NAD |
NAD |
NAD |
Respiratory rate |
NAD |
NAD |
NAD |
Convulsions |
NAD |
NAD |
NAD |
Tremors |
NAD |
NAD |
NAD |
Body temperature (evaluated by touch) |
NAD |
NAD |
NAD |
Muscle tone |
NAD |
NAD |
NAD |
Palpebral opening |
NAD |
NAD |
NAD |
Pupil appearance |
NAD |
NAD |
NAD |
Salivation |
NAD |
NAD |
NAD |
Lachrymation |
NAD |
NAD |
NAD |
Righting reflex |
NAD |
NAD |
NAD |
Back hair appearance |
NAD |
NAD |
NAD |
Other |
NAD |
NAD |
NAD |
MORTALITY |
0 |
0 |
0 |
Key:NAD = no abnormality detected
Table 4: Clinical observations from day 1 to day 14; test group 2; retest dose level 2000 mg/kg
Observation from day 1 to day 14 |
Test group 2 (2000 mg/kg) |
||
T4 |
T5 |
T6 |
|
Spontaneous activity |
NAD |
NAD |
NAD |
Preyer’s reflex (noise) |
NAD |
NAD |
NAD |
Respiratory rate |
NAD |
NAD |
NAD |
Convulsions |
NAD |
NAD |
NAD |
Tremors |
NAD |
NAD |
NAD |
Body temperature (evaluated by touch) |
NAD |
NAD |
NAD |
Muscle tone |
NAD |
NAD |
NAD |
Palpebral opening |
NAD |
NAD |
NAD |
Pupil appearance |
NAD |
NAD |
NAD |
Salivation |
NAD |
NAD |
NAD |
Lachrymation |
NAD |
NAD |
NAD |
Righting reflex |
NAD |
NAD |
NAD |
Back hair appearance |
NAD |
NAD |
NAD |
Other |
NAD |
NAD |
NAD |
MORTALITY |
0 |
0 |
0 |
Key: NAD = no abnormality detected
Table 5: Body weight and weight gain in grams
Test group |
Animal ID |
Day |
||||
D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||
1 |
T1 |
198.0 |
230.2 |
32.2 |
235.5 |
37.5 |
T2 |
192.0 |
227.6 |
35.6 |
240.0 |
48.0 |
|
T3 |
188.0 |
225.2 |
37.0 |
239.8 |
51.8 |
|
2 |
T4 |
212.0 |
245.3 |
33.3 |
248.7 |
36.7 |
T5 |
213.0 |
244.8 |
31.8 |
242.3 |
29.3 |
|
T6 |
220.0 |
260.1 |
40.1 |
272.7 |
52.7 |
NECROPSY FINDINGS
Table 6. Macroscopic observations, test group 1, dose level 2000 mg/kg
Observed organs |
Test group 1 (2000 mg/kg) |
||
T1 |
T2 |
T3 |
|
Oesophagus |
NAD |
NAD |
NAD |
Stomach |
NAD |
NAD |
NAD |
Duodenum |
NAD |
NAD |
NAD |
Jejunum |
NAD |
NAD |
NAD |
Ileum |
NAD |
NAD |
NAD |
Caecum |
NAD |
NAD |
NAD |
Colon |
NAD |
NAD |
NAD |
Rectum |
NAD |
NAD |
NAD |
Spleen |
NAD |
NAD |
NAD |
Liver |
NAD |
NAD |
NAD |
Thymus |
NAD |
NAD |
NAD |
Trachea |
NAD |
NAD |
NAD |
Lungs |
NAD |
NAD |
NAD |
Heart |
NAD |
NAD |
NAD |
Kidneys |
NAD |
NAD |
NAD |
Urinary bladder |
NAD |
NAD |
NAD |
Ovaries |
NAD |
NAD |
NAD |
Uterus |
NAD |
NAD |
NAD |
Adrenals |
NAD |
NAD |
NAD |
Pancreas |
NAD |
NAD |
NAD |
Key: NAD = no abnormality detected
Table 7. Macroscopic observations, test group 2, dose level 2000 mg/kg
Observed organs |
Test group 1 (2000 mg/kg) |
||
T4 |
T5 |
T6 |
|
Oesophagus |
NAD |
NAD |
NAD |
Stomach |
NAD |
NAD |
NAD |
Duodenum |
NAD |
NAD |
NAD |
Jejunum |
NAD |
NAD |
NAD |
Ileum |
NAD |
NAD |
NAD |
Caecum |
NAD |
NAD |
NAD |
Colon |
NAD |
NAD |
NAD |
Rectum |
NAD |
NAD |
NAD |
Spleen |
NAD |
NAD |
NAD |
Liver |
NAD |
NAD |
NAD |
Thymus |
NAD |
NAD |
NAD |
Trachea |
NAD |
NAD |
NAD |
Lungs |
NAD |
NAD |
NAD |
Heart |
NAD |
NAD |
NAD |
Kidneys |
NAD |
NAD |
NAD |
Urinary bladder |
NAD |
NAD |
NAD |
Ovaries |
NAD |
NAD |
NAD |
Uterus |
NAD |
NAD |
NAD |
Adrenals |
NAD |
NAD |
NAD |
Pancreas |
NAD |
NAD |
NAD |
Key: NAD = no abnormality detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test material "M 14-30 Copper-II-pyrophosphate" is higher than 2000 mg/kg body weight by oral route in rat. At this dose level, no mortality occurred and there were no adverse effects on clinical signs and body weight gain or abnormal necropsy finding that could be attributed to treatment with the test material. Therefore, the test material is "not classified" according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.
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