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EC number: 952-026-5 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Skin sensitistion information on Synthetic Wollastonite is not available. A Skin sensitisation study (OECD 429) on the analogue substance Kieselguhr soda ash flux calcined concluded that it was not a skin sensitizer in accordance with the local lymph node assay.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- The study was performed between 01 June 2010 and 24 June 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- The use of data derived for Soda-ash flux calcined kieselghur are justified for read-across to
synthetic wollastonite. Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for Soda-ash flux calcined kieselghur and synthetic wollastonite.
Considering the available data:
The source substance show no concerns for the environment.
The source substance has low acute toxicity and low toxicity in repeated dose studies, is non-irritant (skin and eye), non-sensitizing, non-mutagenic to bacteria, non-cytogenic and has low toxicity for reproductive and developmental toxicity.
Please see RAAF attached in Section 13. for further details. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: Individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet: 2014 Tekland Global Rodent diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 - 70 %
- Air changes: Approximately 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light - Vehicle:
- propylene glycol
- Concentration:
- Groups of four mice were treated with the test material at concentrations of 10%, 5% or 2.5% w/w in propylene glycol
- No. of animals per dose:
- 4 mice per dose
- Details on study design:
- PRELIMINARY SCREENING TEST:
Using available information regarding the systemic toxicity/irritancy potential of the test material, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µl of the test material at a concentration of 10% w/w in propylene glycol, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. The bodyweight was recorded on Day 1 (prior to dosing) and on Day 6
MAIN STUDY:
Groups of four mice were treated with the test material at concentrations of 10%, 5% or 2.5% w/w in propylene glycol. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
3H-Methyl Thymidine Administration
Five days following the first topical application of the test material or vehicle (Day 6) all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR: 80 µCi/ml, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 µCi to each mouse - Positive control substance(s):
- other: Phenylacetaldehyde (90%)
- Positive control results:
- A group of five animals was treated with 50 µl (25 µl per ear) of Phenylacetaldehyde (90%) as a solution in propylene glycol at a concentration of 2.5% v/v. A further control group of five animals was treated with propylene glycol alone
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group was 18.43.
Phenylacetaldehyde (90%) was considered to be a sensitiser under the conditions of the test - Key result
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 4 animals: 2.5 % in propylene glycol
- Key result
- Parameter:
- SI
- Value:
- 0.97
- Test group / Remarks:
- 4 animals: 5 % in propylene glycol
- Key result
- Parameter:
- SI
- Value:
- 0.99
- Test group / Remarks:
- 4 animals: 10 % in propylene glycol
- Interpretation of results:
- not sensitising
- Conclusions:
- The analogue substance Kieselguhr soda ash flux calcined is not classified as a skin sensitiser in accordance with CLP Regulation (EC) no. 1272/2008
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 01 June 2010 and 24 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: Individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet: 2014 Tekland Global Rodent diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25°C
- Humidity: 30 - 70 %
- Air changes: Approximately 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light - Vehicle:
- propylene glycol
- Concentration:
- Groups of four mice were treated with the test material at concentrations of 10%, 5% or 2.5% w/w in propylene glycol
- No. of animals per dose:
- 4 mice per dose
- Details on study design:
- PRELIMINARY SCREENING TEST:
Using available information regarding the systemic toxicity/irritancy potential of the test material, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µl of the test material at a concentration of 10% w/w in propylene glycol, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. The bodyweight was recorded on Day 1 (prior to dosing) and on Day 6
MAIN STUDY:
Groups of four mice were treated with the test material at concentrations of 10%, 5% or 2.5% w/w in propylene glycol. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
3H-Methyl Thymidine Administration
Five days following the first topical application of the test material or vehicle (Day 6) all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR: 80 µCi/ml, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 µCi to each mouse - Positive control substance(s):
- other: Phenylacetaldehyde (90%)
- Positive control results:
- A group of five animals was treated with 50 µl (25 µl per ear) of Phenylacetaldehyde (90%) as a solution in propylene glycol at a concentration of 2.5% v/v. A further control group of five animals was treated with propylene glycol alone
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group was 18.43.
Phenylacetaldehyde (90%) was considered to be a sensitiser under the conditions of the test - Key result
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 4 animals: 2.5 % in propylene glycol
- Key result
- Parameter:
- SI
- Value:
- 0.97
- Test group / Remarks:
- 4 animals: 5 % in propylene glycol
- Key result
- Parameter:
- SI
- Value:
- 0.99
- Test group / Remarks:
- 4 animals: 10 % in propylene glycol
- Interpretation of results:
- not sensitising
- Conclusions:
- Kieselguhr soda ash flux calcined is not classified as a skin sensitiser in accordance with CLP Regulation (EC) no. 1272/2008
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Table 1: Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (%w/w) in |
Animal Number |
Bodyweight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
10 |
S-1 |
19 |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 2: Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
6210.33 |
776.29 |
na |
na |
2.5 |
7020.81 |
877.60 |
1.13 |
Negative |
5 |
6047.51 |
755.94 |
0.97 |
Negative |
10 |
6135.29 |
766.91 |
0.99 |
Negative |
dpm= Disintegrations per minute
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b= Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Table 3: Individual Clinical Observations and Mortality Data
Concentration |
Animal Number |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.5 |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
4-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 4: Individual Bodyweights and Bodyweight Changes
Concentration |
Animal Number |
Bodyweight (g) |
Bodyweight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
1-1 |
20 |
20 |
0 |
1-2 |
20 |
21 |
1 |
|
1-3 |
17 |
17 |
0 |
|
1-4 |
18 |
17 |
-1 |
|
2.5 |
2-1 |
18 |
17 |
-1 |
2-2 |
19 |
19 |
0 |
|
2-3 |
19 |
19 |
0 |
|
2-4 |
19 |
19 |
0 |
|
5 |
3-1 |
20 |
20 |
0 |
3-2 |
20 |
19 |
-1 |
|
3-3 |
18 |
18 |
0 |
|
3-4 |
20 |
20 |
0 |
|
10 |
4-1 |
17 |
17 |
0 |
4-2 |
21 |
20 |
-1 |
|
4-3 |
18 |
18 |
0 |
|
4-4 |
20 |
20 |
0 |
Table 1: Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (%w/w) in |
Animal Number |
Bodyweight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
10 |
S-1 |
19 |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 2: Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
6210.33 |
776.29 |
na |
na |
2.5 |
7020.81 |
877.60 |
1.13 |
Negative |
5 |
6047.51 |
755.94 |
0.97 |
Negative |
10 |
6135.29 |
766.91 |
0.99 |
Negative |
dpm= Disintegrations per minute
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b= Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Table 3: Individual Clinical Observations and Mortality Data
Concentration |
Animal Number |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.5 |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
4-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 4: Individual Bodyweights and Bodyweight Changes
Concentration |
Animal Number |
Bodyweight (g) |
Bodyweight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
1-1 |
20 |
20 |
0 |
1-2 |
20 |
21 |
1 |
|
1-3 |
17 |
17 |
0 |
|
1-4 |
18 |
17 |
-1 |
|
2.5 |
2-1 |
18 |
17 |
-1 |
2-2 |
19 |
19 |
0 |
|
2-3 |
19 |
19 |
0 |
|
2-4 |
19 |
19 |
0 |
|
5 |
3-1 |
20 |
20 |
0 |
3-2 |
20 |
19 |
-1 |
|
3-3 |
18 |
18 |
0 |
|
3-4 |
20 |
20 |
0 |
|
10 |
4-1 |
17 |
17 |
0 |
4-2 |
21 |
20 |
-1 |
|
4-3 |
18 |
18 |
0 |
|
4-4 |
20 |
20 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Read-Across Justification for skin sensitization
Synthetic wollastonite is a UVCB substance, the main constituents of which are amorphous in nature. It also contains crystalline silica. The percentage of crystalline silica may range up to 1.5% (<=0.21% respirable). The skin sensitivity information has been read-across from the analogue substance Kieselguhr, soda ash flux-calcined. The analogue has been chosen for its similarity in structure and properties to Synthetic wollastonite. The main difference in structure between Synthetic wollastonite and Kieselguhr, soda ash flux-calcined is the presence of a calcium ion in Synthetic wollastonite. It is clear from a number of studies carried out on amorphous and crystalline silica and the analogue substance Silicic acid, calcium salt that results were consistent between the two substances and that there was no effect from the presence of the calcium ion. Moreover, it is well documented that these substances have a low potential for hazard to health and the environment.
The toxicological properties of both forms are well described and may be used to predict the sensitizing effects of exposure to Synthetic wollastonite, and to support the available data for this substance.
In the key study (Bradshaw 2010) performed on the analogue substance Kieselguhr soda ash flux calcined, skin sensitisation was assessed using the local lymph node assay. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a suspension in propylene glycol at concentrations of 10%,5% or2.5% w/w. A further group of four animals were treated with propylene glycol alone. The test material was considered to be a non-sensitiser under the conditions of the test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the result of the study on the analogue substance Kieselguhr soda ash flux calcined, Synthethic Wollastonite was not considered to be a skin sensitiser in the LLNA and therefore does not warrant classification in accordance with 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.
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.