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EC number: 814-233-8 | CAS number: 444649-70-1
- 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
The oral LD50 of the test substance was determined to be >2,000 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:
- From June 09, 2015 to June 26, 2015
- 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)
- Deviations:
- yes
- Remarks:
- typing error
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Batch no.: JBGJ0045R
Appearance: clear yellowish liquid - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Velaz Prague, Czech Republic
Age: At least 8-12 weeks; female animals were non-pregnant and nulliparous
Acclimatization: at least 5 days
Temperature: 22 ± 2°C, relative humidity : 55 ± 10% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany, ad libitum
Water: tap water for human consumption, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (carboxymethyl cellulose - 1% solution) shortly before administration. The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test substance administered. After the test isubstance had been administered, food was withheld for further 3-4 hours.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 6 females
- Control animals:
- no
- Details on study design:
- - Animals were observed individually immediately after the administration of the test substance and then ½, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual weights of animals were determined shortly before the test substance was administered and at weekly thereafter. Weight differences after first and second week after application were calculated and recorded.
- All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal. - Preliminary study:
- The starting dose was selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg bw. Available information indicated that the test substance is likely to be nontoxic considering to acute toxicity. A limit dose of 2000 mg/kg bw was used as starting dose. Group of 3 rat’s females were dosed. Test substance-related mortality was not produced during 24 hours; group of 3 rat’s females and group of 3 rat’s males were tested at the same dose.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All 6/6 females and 3/3 males survived the limit dose 2000 mg/kg bw. No further dosing was necessary.
- Clinical signs:
- other: No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.
- Gross pathology:
- All animals (6 females and 3 males) were necropsied. During necropsy, no macroscopically changes were noticed.
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, in compliance with GLP. The test substance was administered by gavage to 6 female and 3 male rats at a limit dose of 2000 mg/kg bw. All 6/6 females and 3/3 males survived the limit dose of 2000 mg/kg bw. No further dosing was necessary. No body weight losses were recorded one and two weeks after administration of the test substance. No important symptoms were observed at the dosage of 2000 mg/kg bw during first 4 h neither in females nor in males or in 14 day observation period. During necropsy, no macroscopically changes were noticed. Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw (Hozova, 2015).
Reference
Based on the results, the test substance was classified in category 5/Unclassified with the cut off LD50 ≥ 5000 mg/kg bw, after single oral administration to Wistar rats.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Guideline compliant study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, in compliance with GLP. The test substance was administered by gavage to 6 female and 3 male rats at a limit dose of 2000 mg/kg bw. All 6/6 females and 3/3 males survived the limit dose of 2000 mg/kg bw. No further dosing was necessary. No body weight losses were recorded one and two weeks after administration of the test substance. No important symptoms were observed at the dosage of 2000 mg/kg bw during first 4 hours neither in females nor in males or in 14 day observation period. During necropsy, no macroscopically changes were noticed. Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw (Hozova, 2015).
Justification for classification or non-classification
Based on the results of an acute oral toxicity study, the test substancedoes not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC).
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