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EC number: 232-113-8 | CAS number: 7787-41-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2017 - April 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Test data is required for classification purposes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Procedures and facilities comply with the requirements of Directive 2010/63/EU [7] and the national legislation defined in the animal protection law concerning the protection of animals used for experimental and other scientific procedures
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The GLP certificate is included within the attached study report
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Barium selenate
- EC Number:
- 232-113-8
- EC Name:
- Barium selenate
- Cas Number:
- 7787-41-9
- Molecular formula:
- Ba.H2O4Se
- IUPAC Name:
- barium selenate
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Analytical purity – 97.60% (BaSeO4)
Physical state – Rhombohedral crystals
Colour – White
Molecular weight – 280.32 g/mol
Expiry date – 24th April 2019
Storage conditions – Room temperature
Stability under test conditions - Acceptable
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- healthy CBA/CaOlaHsd mice
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare the animals were bred for experimental purposes.
This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.
Housing and Feeding Conditions
• Full barrier in an air-conditioned room
• Temperature: 22 ± 3 °C
• Relative humidity: 55 ± 10%
• Artificial light, sequence being 12 hours light, 12 hours dark
• Air change: at least 10 x / hour
• Free access to Altromin 1324 maintenance diet for rats and mice
• Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
• The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding
• Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
• Adequate acclimatisation period (at least five days) under laboratory conditions
Clinical Observation
Prior to the application and once a day thereafter all animals were observed in order to detect signs of toxicity, including dermal irritation at site of application.
Weight Assessment
The animals were weighed prior to the application and at the end of the test period (prior to the treatment with 3HTdR).
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Pretest concentrations: 12.5 %, 25%, 50% and 100% Barium Selenate in DMSO
Main test: 0.75%, 1.5% and 3% Barium selenate in DMSO - No. of animals per dose:
- 2
- Details on study design:
- Topical Application
Each mouse was treated by topical application of 25 µL of the selected solution to the entire dorsal surface of each ear.
Topical applications were performed once daily over three consecutive days. The first treatment day is defined as study day 1.
Administration of 3H-Methyl Thymidine
Five days after the first topical application all mice were dosed with 20 µCi 3H-methyl thymidine by intravenous injection (tail vein) of 250µL of 3H-methyl thymidine, diluted with PBS to a working concentration of 80 µCi/mL.
Preparation of Cell Suspension
Approximately 5 hours after the injection of 3H-methyl thymidine all mice were sacrificed by cervical dislocation. The draining auricular lymph nodes were excised, weighed, individually pooled for each animal (2 lymph nodes per animal) and collected in phosphate buffered saline (PBS). A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze (200 mesh size). After washing the gauze with PBS the cell suspension was pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure was repeated.
After the final wash each pellet was resuspended in approx. 1 mL 5% TCA at approx. 4° C for approximately 18 hours for precipitation of macromolecules. Each precipitate was once washed again, resuspended in 1 mL 5% TCA and 7 mL scintillation fluid was added. Then this solution was transferred into scintillation vials and stored at room temperature overnight.
Determination of Incorporated 3H -Methyl Thymidine
The 3H-methyl thymidine – incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Similarly, background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually for each animal. - Positive control substance(s):
- other: Phenylenediamine in DMSO
- Statistics:
- The proliferative response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (DPM/NODE) and as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to that recorded for control group animals (STIMULATION INDEX). Before DPM/NODE values were determined, background values were subtracted.
EC3 values, calculated concentrations which induce stimulation indices of three, are determined by linear interpolation, EC3=c+[(3-d)/(b-d)]x(a c), between two points of the stimulation indices axis, one above (a,b) and one below (c,d) the stimulation index of three. If all measured points are above or below the stimulation index of three, no EC3 value can be stated.
A substance is regarded as a 'sensitiser' in the LLNA if at least one concentration of the test item results in a 3-fold or greater increase in 3H-methyl thymidine - incorporation into lymph node cells of the test group animals, relative to that recorded for the lymph nodes of control group animals (Stimulation Index equal to or greater than 3.0).
On the basis of the test results, the test substance may be classified into one of the following categories in conformity with the criteria given in Commission Regulation (EU) No 286/2011 as well as in GHS - Globally Harmonised System of Classification and Labelling of Chemicals, seventh revised edition, 2017.
Results and discussion
- Positive control results:
- Refer to table in “Any other information on results incl. tables”
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Test group 1 (0.75%)
- Remarks on result:
- other: Acceptable, EC3 is <3
- Key result
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- Test group 2 (1.5%)
- Remarks on result:
- other: Acceptable, EC3 is <3
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Test group 3 (3%)
- Remarks on result:
- other: Acceptable, EC3 is <3
- Cellular proliferation data / Observations:
- Not calculated as stimulation indices of all concentrations were below 3.
Any other information on results incl. tables
Radioactive Determination of the Test Substance– Main Study–Test Groups 1 and 2
POS |
CPM |
Test Item |
Conc. [%] |
Animal number |
DPM |
DPM mean background |
DPM / node |
Simulation index |
16 |
876.0 |
Negative control |
100 |
411 |
1766.0 |
1716.8 |
858.4 |
|
17 |
1083.0 |
412 |
2187.0 |
2137.8 |
1068.9 |
|
||
18 |
1328.0 |
413 |
2684.0 |
2634.8 |
1317.4 |
|
||
19 |
554.0 |
414 |
1115.0 |
1065.8 |
532.9 |
|
||
20 |
1450.0 |
415 |
2923.0 |
2873.8 |
1436.9 |
|
||
MV |
1058.2 |
MV |
2135.0 |
2085.8 |
1042.9 |
1.0 |
||
SD |
320.7 |
SD |
648.3 |
648.3 |
324.2 |
|
||
26 |
373.0 |
Barium Selenate in DMSO |
0.75 |
16 |
719.0 |
669.8 |
334.9 |
0.3 |
27 |
1980.0 |
17 |
2181.0 |
2131.8 |
1065.9 |
1.0 |
||
28 |
1039.0 |
18 |
2089.0 |
2039.8 |
1019.9 |
1.0 |
||
29 |
1351.0 |
19 |
2751.0 |
2701.8 |
1350.9 |
1.3 |
||
30 |
623.0 |
20 |
1246.0 |
1196.8 |
598.4 |
0.6 |
||
MV |
893.6 |
MV |
1797.2 |
1748.0 |
874.0 |
0.8 |
||
SD |
349.3 |
SD |
722.3 |
722.3 |
361.1 |
0.3 |
||
31 |
1178.0 |
Barium Selenate in DMSO |
1.5 |
21 |
2365.0 |
2315.8 |
1157.9 |
1.1 |
32 |
2090.0 |
22 |
4207.0 |
4157.8 |
2078.9 |
2.0 |
||
33 |
2823.0 |
23 |
5734.0 |
5684.8 |
2842.4 |
2.7 |
||
34 |
1649.0 |
24 |
3300.0 |
3250.8 |
1625.4 |
1.6 |
||
35 |
923.0 |
25 |
1837.0 |
1787.8 |
893.9 |
0.9 |
||
MV |
1732.6 |
MV |
3488.6 |
3439.4 |
1719.7 |
1.6 |
||
SD |
676.3 |
SD |
1384.5 |
1384.5 |
692.2 |
0.7 |
||
76 |
56.0 |
Background Szinti and TCA |
|
|
108.0 |
|
|
|
77 |
9.0 |
|
|
17.0 |
|
|
|
|
78 |
32.0 |
|
|
61.0 |
|
|
|
|
79 |
11.0 |
|
|
21.0 |
|
|
|
|
80 |
20.0 |
|
|
39.0 |
|
|
|
|
MV |
25.6 |
|
MV |
49.2 |
0.0 |
0.0 |
0.0 |
|
SD |
17.2 |
|
SD |
33.3 |
|
|
|
If not noted individually, the results include both lymph nodes of an animal.
POS = position in counter; CPM = counts per
minute; Conc. = concentration; DPM = disintegrations
per minute; SD = standard deviation; MV = mean value; Szinti =
scintillation fluid; TCA = trichloro-
acetic acid
Radioactive Determination of the Test Substance– Main Study–Test Group 3
POS |
CPM |
Test Item |
Conc. [%] |
Animal number |
DPM |
DPM mean background |
DPM / node |
Simulation index |
16 |
153.0 |
Negative control |
100 |
401 |
286.0 |
270.2 |
135.1 |
|
17 |
165.0 |
402 |
309.0 |
293.2 |
146.6 |
|
||
18 |
310.0* |
403 |
575.0* |
n.d. |
n.d. |
|
||
19 |
169.0 |
404 |
313.0 |
297.2 |
148.6 |
|
||
20 |
173.0 |
405 |
333.0 |
317.2 |
158.6 |
|
||
MV |
165.0 |
MV |
310.3 |
294.5 |
147.2 |
1.0 |
||
SD |
7.5 |
SD |
16.7 |
16.7 |
8.3 |
|
||
1 |
177.0 |
Background Selenate in DMSO |
3 |
1 |
338.0 |
322.2 |
161.1 |
1.1 |
2 |
145.0 |
2 |
274.0 |
258.2 |
129.1 |
0.9 |
||
3 |
344.0* |
3 |
636.0* |
n.d. |
n.d. |
n.d. |
||
4 |
98.0 |
4 |
180.0 |
164.2 |
82.1 |
0.6 |
||
5 |
103.0 |
5 |
190.0 |
174.2 |
87.1 |
0.6 |
||
MV |
130.8 |
MV |
245.5 |
229.7 |
114.9 |
0.8 |
||
SD |
32.3 |
SD |
64.7 |
64.7 |
32.3 |
0.2 |
||
66 |
8.0 |
Background Szinti and TCA |
|
|
14.0 |
|
|
|
67 |
8.0 |
|
15.0 |
|
|
|
||
68 |
8.0 |
|
16.0 |
|
|
|
||
69 |
10.0 |
|
19.0 |
|
|
|
||
70 |
8.0 |
|
15.0 |
|
|
|
||
MV |
8.4 |
MV |
15.8 |
0.0 |
0.0 |
0.0 |
||
SD |
0.8 |
SD |
1.7 |
|
|
|
* = outlier, failed Grubbs, Nalimov and Dixon; n.d. = not determined
If not noted individually, the results include both lymph nodes of an animal.
POS = position in counter; CPM = counts per
minute; Conc. = concentration; DPM = disintegrations
per minute; SD = standard deviation; MV = mean value; Szinti =
scintillation fluid; TCA = trichloro-
acetic acid
Radioactive Determination of the Positive-Control Groupof the Current Study (14 March 2018)
POS |
CPM |
Test Item |
Conc. [%] |
Animal number |
DPM |
DPM mean background |
DPM / node |
Simulation index |
16 |
153.0 |
Negative control |
100 |
401 |
286.0 |
270.2 |
135.1 |
|
17 |
165.0 |
402 |
309.0 |
293.2 |
146.6 |
|
||
18 |
310.0* |
403 |
575.0* |
n.d. |
n.d. |
|
||
19 |
169.0 |
404 |
313.0 |
297.2 |
148.6 |
|
||
20 |
173.0 |
405 |
333.0 |
317.2 |
158.6 |
|
||
MV |
165.0 |
MV |
310.3 |
294.5 |
147.2 |
1.0 |
||
SD |
7.5 |
SD |
16.7 |
16.7 |
8.3 |
|
||
21 |
177.0 |
Background Selenate in DMSO |
1 |
406 |
2360.0 |
2344.2 |
1172.1 |
8.0 |
22 |
145.0 |
407 |
3172.0 |
3156.2 |
1578.1 |
10.7 |
||
23 |
344.0* |
408 |
1739.0 |
1723.2 |
861.6 |
5.9 |
||
24 |
98.0 |
409 |
1808.0 |
1792.2 |
896.1 |
6.1 |
||
25 |
103.0 |
410 |
3431.0 |
3415.2 |
1707.6 |
11.6 |
||
MV |
130.8 |
MV |
2502.0 |
2486.2 |
1243.1 |
8.4 |
||
SD |
32.3 |
SD |
692.2 |
692.2 |
346.1 |
2.4 |
||
66 |
8.0 |
Background Szinti and TCA |
|
|
14.0 |
|
|
|
67 |
8.0 |
|
15.0 |
|
|
|
||
68 |
8.0 |
|
16.0 |
|
|
|
||
69 |
10.0 |
|
19.0 |
|
|
|
||
70 |
8.0 |
|
15.0 |
|
|
|
||
MV |
8.4 |
MV |
15.8 |
0.0 |
0.0 |
0.0 |
||
SD |
0.8 |
SD |
1.7 |
|
|
|
If not noted individually, the results include both lymph nodes of an animal.
POS = position in counter; CPM = counts per
minute; Conc. = concentration; DPM = disintegrations
per minute; SD = standard deviation; MV = mean value; Szinti =
scintillation fluid; TCA = trichloro-
acetic acid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Unclassified
- Conclusions:
- The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
Consequently, according to OECD 429 the test item Barium Selenate as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.
The results of radioactivity determination are supported by the means of the lymph node weights per group, which showed no relevant difference compared to the negative control.
According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System) the test item Barium Selenate has no obligatory labelling requirement for skin sensitisation and is unclassified. - Executive summary:
The potential for Barium Selenate to induce sensitisation was analysed using the LLNA (Local Lymph Node Assay - LLNA) method. The in vivo test system used mice; strain - CBA/CaOlaHsd, sex - female (nulliparous and non-pregnant).
The main study was started with test item concentrations of 3%, 6.25% and 12.5% based on the results observed in the pre-screen test. However, severe signs of systemic toxicity or mortality were found in all animals of the 12.5% dose group. In the 6.25% dose group two animals had to be euthanised due to animal welfare reasons and after showing severe signs of systemic toxicity. No toxic effects were observed in any animal of the 3% dose group. As the results obtained with the dose groups 6.25% and 12.5% were insufficient for skin sensitisation evaluation, they were excluded for further evaluation.
However, to provide sufficient data for skin sensitisation assessment of the test item Barium Selenate according to OECD 429, the main study was extended by two dose groups with test item concentrations of 0.75 % and 1.5%.
Accordingly, the three dose groups with test item concentrations of 0.75% (test group 1), 1.5% (test group 2) and 3% (test group 3) were used for evaluation. Stimulation indices of 0.8, 1.6 and 0.8 were obtained for the dose groups 0.75, 1.5 and 3% respectively. The EC3 value could not be calculated due to the stimulation indexes being below 3 and as such the test item is not considered to be a dermal sensitiser.
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