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EC number: 268-460-7 | CAS number: 68092-47-7
- 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
Acute oral toxicity (OECD 423, GLP): LD50 value: 300 < LD50 ≤ 2000 mg/ kg bw
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
- Study period:
- 2017-11-27 to 2017-12-20
- 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:
- 2001-12-17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2015-06-05
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, < 30°C - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9-10 weeks
- Weight at study initiation: 165 - 184 g
- Fasting period before study: prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: animals were kept in groups of three in IVC cages, type III H, polysulphone cages; bedding material: Altromin saw fibre bedding
- Diet (ad libitum, for exception refer to "fasting period before study" above): Altromin 1324 maintenance diet for rats and mice (Altromin Spezialfutter GmbH & Co. KG, Im Seelenkamp 20, 32791 Lage, Germany)
- Water (ad libitum): tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C ± 3 °C
- Relative humidity: 55 % ± 10%
- Air changes: 10 x / hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Source: Sigma-Aldrich Chemie GmbH, Riedstrasse 2, 89555 Steinheim, Germany
- Justification for choice of vehicle: this vehicle was chosen due to its non-toxic characteristics
- Lot no.: MKCC0462
- Expiry date: 2018-01-31 - Doses:
- Starting dose (step 1): 300 mg/kg bw
Step 2: 2000 mg/kg bw
Step 3: 300 mg/kg bw - No. of animals per sex per dose:
- 9 female rats (3 animals/step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. The animals which died spontaneously during the observation period were necropsied as soon as they were killed. - Statistics:
- No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).
- Preliminary study:
- not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg /kg bw: no animals died
2000 mg/kg bw: all animals died prematurely - Clinical signs:
- other: 300 mg/kg bw after 0-30 min: slightly reduced spontaneous activity, hunched posture, slight/moderate piloerection, prone position after 30-60 min: moderately reduced spontaneous activity, hunched posture, moderate piloerection, prone position, sunken flun
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 value: 300 < LD50 ≤ 2000 mg/ kg bw
According to the Regulation (EC) NO 1272/2008 and subsequent adaptations, the substance is classified as acute toxic via the oral route (Cat.4; H302).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- key study available
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Barium m-toluate
One acute toxicity study in rats (key study) via the oral route with barium m-toluate is available, resulting in a LD50 in the range of 300 to 2000 mg/kg bw.
Barium m-toluate was administered in three steps at doses of 300 and 2000 mg/kg bw to female Wistar Crl:WI (Han) rats. All animals were observed daily for a period of 14 days. Individual body weights were recorded before administration and thereafter in weekly intervals. At the end of the study all animals were sacrificed, dissected and inspected macroscopically. At 300 mg/kg bw no mortality and changes in body weight or pathological changes were observed. At 2000 mg/kg bw all animals died prematurely. The LD50 results in a classification of the barium m-toluate for acute toxicity via the oral route Category 4 and is in line with the legally binding harmonised classification of barium salts ((EC) No 1272/2008; Index No. 056-002-00-7). The read-across to data of the barium chloride dossier (assessment entity barium cations), which was itself classified as acute toxic via the oral route Category 3 thus represents an overly conservative approach for read-across.
The acute oral toxicity study was conducted as a bridging study for systemic effects displaying the applicability to read-across to the assessment entities barium cations and m-toluic acid anions (for a detailed description of the read-across approach please refer to the separate report attached to section 13).
In the assessment of the systemic toxicity of barium m-toluate, a read-across to data for m-toluic acid and soluble barium substances is applied since only the ions of barium and m-toluate are systemically available and determine the toxicological potential of barium m-toluate.
Signs of acute dermal toxicity are not expected for barium m-toluate, since the two moieties barium and m-toluic acid have not shown signs of acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). Under the assumption that the moieties of barium m-toluate show their toxicological profile individually upon dissolution, the acute dermal toxicity of barium m-toluate can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1.
A study for acute toxicity via inhalation was not conducted with barium m-toluate, since it is produced and placed on the market in a form in which no inhalation hazard is anticipated, thus acute toxic effects are not likely to occur during manufacture and handling of that substance. For further information on the toxicity of the assessment entities, please refer to the relevant sections in the IUCLID and CSR.
Barium
Acute oral toxicity
There are three reliable studies for acute oral toxicity testing (Müller, 1983, Borzelleca, 1988 and Tardiff, 1980). All studies were used in a weight of evidence approach. The study performed by Müller, 1983 results in an LD50of 645 mg BaCl2/kg bw (male/female), the study performed by Borzelleca in 1988 leads to an LD50>100 and <300 mg/kg bw. whereas the study conducted by Tardiff 1980 results in an LD50of 300 mg/kg bw.
Acute dermal toxicity
According to the SIAR 27 prepared for barium dichloride, an acute dermal toxicity study on barium dichloride was conducted according to OECD 402, in compliance with GLP. In this study, the dermal LD50 was greater than 2000 mg BaCl2/kg bw in rats. Nevertheless, primary data could not be made available by the registrant.
m-toluate
Acute oral toxicity
One acute toxicity study in rats (key study) via the oral route with m-toluic acid is available, resulting in LD50 (oral, male and females rats) > 2000 mg/kg bw
According to the EC-Regulation 1272/2008 and subsequent regulations, m-toluic acid is not classified as acute toxic via the oral route.
Acute dermal toxicity
The acute oral toxicity study with m-toluic acid did not show any signs of systemic toxicity upon administration up to the limit dose, indicating a very low systemic toxicity of that substance. The low systemic toxicity is corroborated by supporting evidence in an in vivo study, in which 6 japanese white rabbits were dermally exposed to the substance for 24 hours with a 7 day observation period. No mortality or other clinical signs of systemic toxicity were observed in animals. In accordance with Annex XI, Section 1.2 further testing is considered not to be required, since the overall weight of evidence in experimental animals exposed via dermal and oral route did not indicate any acute toxic effects. Experimental testing is therefore waived.
Justification for classification or non-classification
The LD50 for barium m-toluate is 300 < LD50 ≤ 2000 mg/ kg bw, hence the substance is classified as acute toxic via the oral route Category 4 (H302) in accordance to Regulation (EC) 1272/2008 and subsequent adaptations.
The calculated dermal LD50 for barium m-toluate is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008and subsequent adaptationsfor acute dermal toxicity.
Barium m-toluate is a barium salt and thereforeclassified as acute toxic via the inhalative route Category 4 (H332) according to Annex VI, Index No. 056-002-00-7 of Regulation (EC) 1272/2008.
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