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EC number: 244-007-9 | CAS number: 20749-68-2
- 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
There are 2 acute toxicity studies available using different exposure routes : L 50 (oral): >5000 mg/kg bw and LC50 >2868 mg/m³/4 h. Thus, there is no need to conduct an additional acute toxicity study using the dermal route.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: similar to the respective guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- 10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Tragant and were observed for clinical signs of intoxication, body weight development, mortaliy over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 9 weeks
- Weight at study initiation: 180 g
- Housing: groups of 5
- Diet ad libitum
- Water ad libitum
- Acclimation period: some days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/1 - Route of administration:
- oral: gavage
- Vehicle:
- other: traganth
- Details on oral exposure:
- 10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Tragant
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- 10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Tragant and were observed for clinical signs of intoxication, body weight development, mortaliy over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination.
- Statistics:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no clinical signs, no mortality
- Mortality:
- 0/10
- Clinical signs:
- other: no clicical signs observed
- Gross pathology:
- the animals sacrificed at the end of the study did not show any noticeable pathological findings.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Traganth and were observed for clinical signs of intoxication, body weight development, mortality over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination. No animal died, no clinical signs were observed, all animals gained weight and no gross pathological findings were detected at the terminal sacrifice. Thus the LD50 is > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- rat study according to the respective guideline and GLP and evaluated with Klimisch score 2
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD TG and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2 month
- Weight at study initiation: 180-200 g
- Fasting period before study:
- Housing: before test : singly and during test in groups
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Details on inhalation exposure:
- target concentration 5000 mg/m³
mean gravimetric concentration 2868 mg/m³
maximum technically attainable concentration
inlet air flow 28 l/min (concurrent control : air. 15 l/min)
exhaust air flow: 23.8 l/min (concurrent control: 12.8 l/min)
mean temperature 22.4.°C (concurrent control: 22.4°C
mean rel humidity 10.3 % (concurrent control: 5.1 %)
Mass Median Aerodynamic Diameter(MMAD) 4.78 µm
Aerosol Mass < 3 µm: 22 %
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- target concentration 0 or 5000 µg/m³ (maximum technically attainable mean concentration: 2868 mg/m³)
- No. of animals per sex per dose:
- 5 rats /sex and concentration
- Control animals:
- yes
- Details on study design:
- according to the respective guideline , 2 weeks post exposure observation
To identify exposure related effects, comparisons with an appropriate vehicle control were performed. This control was exposed to an atmosphere using essentially similar exposure conditions as were used for the test substance.
body weight determination on days 1, 3, 7 and weekly thereafter
deaths were recorded
clinical signs and appearance and behavior of each rat were recorded
Necropsy was performed
and gross pathological changes were notet (if available) - Statistics:
- one-way ANOVA
The particle-size distribution was analyzed using an ANDERSEN critical orifice
cascade impactor.
Mass Median Aerodynamic Diameter (MMAD): Construct a 'Cumulative Percent
Found - Less Than Stated Particle Size' Table, calculate the total mass of test
substance collected in the cascade impactor.
Calculation of Geometric Standard Deviation (GSD): Refer to the log probability
graph used to calculate the Mass Median Aerodynamic Diameter - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2 868 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- no rat died
- Clinical signs:
- other: no specific clinical signs were observed
- Body weight:
- Comparisons between the control and the exposure group did not reveal changes in body weights of toxicological significance
in body weights of no toxicological significance - Gross pathology:
- -Animals sacrificed at the end of the observation period:
No macroscopic findings - Other findings:
- no further data
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Executive summary:
A study on acute inhaltion toxicity of Macrolex Rot EG on rats has been conducted in accordance with OECD TG 403. A group of male and female rats was nose-only exposed to the dry powder aerosol of the test article at an actual concentration of 2868 mg/m³.. No animal died, no clinical findings and no pathotlogical changes were noted. Therefore, the results can be summarized as follows:
LC50 (rat) > 2868 mg/m³, the maximum technically attainable concentration.
Reference
Target concentration: 5000 mg/m³
Gravimetric concentration: 2868 mg/m³
MMAD: 4.78 µm
GSD 1.82
Aerosol Mass <3 µm: 22.0 %
Mass recovered: 2228 mg/m³
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 2 868 mg/m³ air
- Quality of whole database:
- guideline study under GLP conditions and evaluated with Klimisch score 1
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ORAL ROUTE
10 male Wistar rats received single oral dose of 5000 mg/kg bw dissolved in 1% Traganth and were observed for clinical signs of intoxication, body weight development, mortality over a period of 14 days. At the end of the observation time all animals undergo gross pathological examination. No animal died, no clinical signs were observed, all animals gained weight and no gross pathological findings were detected at the terminal sacrifice. thus The LD50 is > 5000 mg/kg bw.
INHALATION ROUTEA study on acute inhalation toxicity of Macrolex Rot EG on rats has been conducted in accordance with OECD TG 403. A group of male and female rats was nose-only exposed to the dry powder aerosol of the test article at an actual concentration of 2868 mg/m³.. No animal died, no clinical findings and no pathotlogical changes were noted. Therefore, the results can be summarized as follows:
LC50 (rat) > 2868 mg/m³, the maximum technically attainable concentration.
DERMAL ROUTE
There is no data on acute toxicity available using the dermal exposure route. According to Regulation (EC) No. 1907/2006 (REACH) ANNEX VIII column 2 in addition to the acute toxicity using the oral route for substances other than gases at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an acute inhalation toxicity study according to the respective guideline and GLP evaluated with Klimisch score 1. Thus, there is no need to conduct an acute toxicity study using the dermal route.
Justification for selection of acute toxicity – oral endpoint
only avaialble rat study according to the respective guideline and GLP and evaluated with Klimisch score 2
Justification for selection of acute toxicity – inhalation endpoint
only available study: performed according to the actuell guideline and GLP and evaluated with Klimisch score 1
Justification for selection of acute toxicity – dermal endpoint
There is no data on acute toxicity available using the dermal exposure route. According to Regulation (EC) No. 1907/2006 (REACH) ANNEX VIII column 2 in addition to the acute toxicity using the oral route for substances other than gases at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an acute inhalation toxicity study according to the respective guideline and GLP evaluated with Klimisch score 1. Thus, there is no need to conduct an acute toxicity study using the dermal route.
Justification for classification or non-classification
based on the available data no classification or labelling is required.
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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