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EC number: 269-142-0 | CAS number: 68188-14-7
- 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
Since no experimental data regarding the acute toxicity of the test substance were available, a weight of evidence approach for the endpoint acute oral toxicity was conducted to determine hazard classification. It was concluded that the test substance is harmful by inhalation and if swallowed according to the harmonised classification and labelling for barium salts approved by the European Union (Regulation (EC) 1272/2008 Annex VI; Index-no: 056-002-00-7 / CLP 00).
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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Young female adult animals (approx. 14- 18 weeks) with a comparable weight were used.
Acclimatization for at least 5 days.
Individual animal identification by cage cards and tail marking.
One animal per cage (type: stainless steel wire mesh cages, type DK-lll).
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity.
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum. Feed was withdrawn from the animais at least 16 hours before administration, but water was available ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Olive oil Ph.Eur/DAB had to be used to ensure homogeneity of the preparation.
The test substance preparation was produced for each administration group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax ) and a magnetic stirrer.
Form of administration: suspension
Concentration used: 40 g/100 ml
Application volume: 5 ml/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Observation period: at least 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy with gross-pathological examination on the last day of the observation period after killing with CO2. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: No clinical observations were observed during clinical examination.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (6 females) examined at termination of the study.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: formulation tested. Limit dose for test substance not reached (only 1200 mg/kg bw tested), non GLP, similar to guideline
- Justification for type of information:
- ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- calculated on content of CAS 9008-34-8, dose only 1200 mg/kg bw; higher number of animals, 8 instead of 14 days post-observation.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- content of rosin and resin acids, manganese salts = 12%
other component: poorly soluble manganese complex
Physical state: red solid - Species:
- rat
- Strain:
- other: CFE
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Healthy young random bred rats of the CFE (RAC, SPF) strain purchased from the breeder were used for these experiments. The mean initial body weight was between 129 and 151 g. Before starting, the animals were acclimatized for at least 5 days in our laboratories to a constant room temperature of 22°C, relative humidity of 55 % and 14 hours light/day. They were housed in groups of 5 in macrolon cages (size 3). A standard diet of Nafag and
drinking water were given "ad libitum". - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Rats received by gavage various doses (see table 1 ) of a preparation suspended with 0.5% carboxymethyIcellulose and tap water.
The total volume given was 20 ml/kg body weight. - Doses:
- 5000 and 10000 mg/kg bw (corresponds to 600 and 1200 mg/kg bw of CAS 9008-34-8)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Symptoms and mortality after administration were recorded during an observation period of 8 days.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 1 200 mg/kg bw
- Based on:
- other: content of CAS 9008-34-8
- Remarks on result:
- other: No mortality occurred.
- Clinical signs:
- other: at 10000 mg/kg bw: sedation
- Other findings:
- red stained feces at both doses
red stained urine at 10000 mg/kg bw
The red coloration is caused by the intrinsic color of the main component of the formulation and is not an adverse effect. - Interpretation of results:
- other: Considering the absence of adverse effects at 1200 mg/kg bw, the LD50 is unlikely to be greater than 2000 mg/kg bw.
- Conclusions:
- Considering the absence of adverse effects at 1200 mg/kg bw, the LD50 is unlikely to be greater than 2000 mg/kg bw.
- Executive summary:
In a supporting acute oral toxicity study, the test material (CAS# 9008-34-8; 12% formulation) was administered to young adult CFE rats (5/sex/dose) via oral gavage at doses of 5000 and 10000 mg/Kg bw (corresponding to 600 and 1200 mg/Kg of the test material) in a carboxymethyl cellulose vehicle. No mortality was observed at the highest dose tested.
Considering the absence of adverse effects at 1200 mg/kg bw, the LD50 was determined to be ≥1200 mg/Kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: Publication
- Adequacy of study:
- weight of evidence
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No further information on the test principles, but the LD50 for acute oral toxicity in rats is given.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Statistics:
- No data available.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 118 mg/kg bw
- Based on:
- not specified
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The test substance is legally classified as toxic via ingestion according to Regulation (EC) 1272/2008 Annex VI; Index-no: 056-004-00-8 / CLP00, as amended for the fourteenth time in Regulation (EU) No. 2020/217.
Referenceopen allclose all
RS-Freetext:
- No mortality occurred.
- No clinical signs and findings were observed.
- The mean body weights of the administration groups
increased throughout the study period.
- No macroscopic pathologic abnormalities were noted in the
animals examined at the end of the observation period.
- The median lethal dose of BREMAZIT 5060 after oral
administration was found to be greater than 2,000 mg/kg
body weight in rats.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - see justification attached to IUCLID section 7.2.1 Acute toxicity: oral
- Justification for WoE: Acute oral toxicity
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008:
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. For acute oral toxicity no experimental data of the test substance itself are available. According to the harmonised classification and labelling for barium salts approved by the European Union (Regulation (EC) 1272/2008 Annex VI; Index-no: 056-002-00-7 / CLP 00) and available acute oral toxicity data from read-across, classification with Cat. 4 for acute toxic effects (harmful by inhalation and if swallowed) is warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EU) No. 2020/217.
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