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EC number: 236-715-1 | CAS number: 13466-20-1
- 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
Oral (OECD 423, RL1), rat: LD50 > 300 < 2000 mg/kg bw, LD50 cut-off = 2000 mg/kg bw
Dermal (OECD 402, RL1), rat: LD50 > 2000 mg/kg bw (limit test)
Inhalation: no data available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 173 - 194 g
- Fasting period before study: approx. 16 hours before administration
- Housing: groups of three in MAKROLON cages (type III plus)
- Diet: ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: hydroxypropyl methylcellulose
- Details on oral exposure:
- VEHICLE
0.8% aqueous hydroxypropyl methylcellulose
MAXIMUM DOSE VOLUME APPLIED: 1.3 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: according to the OECD/EC guidelines - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg bw: 1/3 in the first step and 2/3 in the second step
300 mg/kg bw: no animal died prematuraly - Clinical signs:
- 2000 mg/kg bw: slightly to moderately reduced motility, slight to moderate ataxia and slightly to moderately reduced muscle tone in 4 of 6 animals, pilo-erection in all 6 animals and slight dyspnoea in 3 of 6 animals; In addition, pulpy faeces with offensive smell was observed in 2 of 6 animals and a reddish-brown wetted lower jar was noted in 1 of 6 animals.
300 mg/kg bw: no clinical signs observed - Body weight:
- All surviving animals gained the expected weight at the end of the study period.
- Gross pathology:
- No pathological changes were observed at necropsy.
- Interpretation of results:
- other: Category 4 based on CLP criteria (EU GHS criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- Under the present test conditions a LD50 value for Barium bis(dihydrogenorthophosphate between 300 and 2000 mg/kg bw was observed. According to OECD Guideline 423 Annex 2d a LD50 cut off = 2000 mg/kg bw was estimated. Therefore, CLP criteria for Category 4 according to Regulation (EC) No. 1272/2008 are met.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01. November 2016 - 30. January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
- Age at study initiation: males: approx. 8 weeks; females: approx. 9 weeks
- Weight at study initiation: males: 231 - 250 g; females: 230 - 250 g
- Fasting period before study: no
- Housing: singly in MAKROLON cages (type III plus)
- Diet: ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Vehicle:
- DMSO
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back between the fore and hind extremities
- % coverage: 5 cm x 6 cm, approx. 1/10 of body surface
- Type of wrap if used: The test substance was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site.
REMOVAL OF TEST SUBSTANCE
- Washing: not specified
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
- Concentration: 10 g test substance was moistened in 5 g DMSO
- Constant volume or concentration used: not specified
- For solids, paste formed: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: Changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- no signs of toxicity observed
- Body weight:
- expected body weight gain
- Gross pathology:
- no abnormalities observed
- Other findings:
- - Skin reaction: none
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under these test conditions the test substance showed no acute dermal toxicity with a LD50 > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Oral:
The acute oral toxicity of the test substance was assessed in a study performed according to OECD Guideline 423 and in compliance with GLP (LPT, 2017). A group of three fasted female CRL:CD(SD) rats was treated with the test material at a dose level of 2000 mg/kg bw. The test material was administered by gavage formulated in 0.8% aqueous hydroxypropyl methylcellulose at a dosing volume of 1.3 mL/kg bw. The animals were observed for 14 days and body weights were measured. All animals were subjected to a necropsy and a macroscopic examination. In this first step 1 of 3 female rats died. After treatment of 3 additional rats with 2000 mg/kg bw test substance in a second step 2 of 3 rats died. After treating 3 further female rats with 300 mg/kg bw no mortality was observed and a confirmatory group of three fasted females was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD Guideline 423. Treatment with the test substance at 2000 mg/kg bw revealed slightly to moderately reduced motility, slight to moderate ataxia and slightly to moderately reduced muscle tone in 4 of 6 animals, pilo-erection in all 6 animals and slight dyspnoea in 3 of 6 animals. In addition, pulpy faeces with offensive smell were observed in 2 of 6 animals and a reddish-brown wetted lower jar was noted in 1 of 6 animals. Oral administration of 300 mg/kg bw test substance did not reveal any changes. No abnormalities were noted at necropsy at dose levels of 2000 and 300 mg/kg bw. All surviving animals gained the expected weight at the end of the study period. Thus, under the conditions of this study, the acute oral LD50 value of the test substance was found to be between 300 and 2000 mg/kg bw in female rats. The LD50 cut-off value according to OECD 423 guideline is 2000 mg/kg bw.
Dermal:
The acute dermal toxicity of the test substance was assessed in a study performed according to OECD Guideline 402 and in compliance with GLP (LPT, 2017). Five male and five female CRL:CD(SD) rats were treated with the test substance by a single occlusive dermal application at 2000 mg/kg bw (limit test). The animals were observed for 14 days and body weights were measured. All animals were subjected to a necropsy and a macroscopic examination. Furthermore skin irritation scores were evaluated during the observation period. No mortality occurred and no clinical signs or local dermal signs were observed. There were no treatment related effects on body weight or body weight gain. There was no evidence of any observations at a dose level of 2000 mg/kg bw at necropsy. Thus, under the conditions of this study, the acute dermal LD50 value of the test substance was found to be > 2000 mg/kg bw in male and female CRL:CD(SD) rats.
Inhalation:
An acute inhalation toxicitiy study is technically not feasible due to the hygroscopic properties of the test substance. Furthermore, because of the harmonised classification for Barium compounds, the test substance is classified for acute inhalation toxicity (Cat. 4).
Justification for classification or non-classification
The available data on acute oral toxicity meet the criteria for classification according to Regulation (EC) 1272/2008, and is therefore classified as acute toxic Category 4 (H302).
The available data on acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
A harmonised classification for Barium compounds are available, therefore the test substance is classified for acute inhalation toxicity (Cat. 4, H332).
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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