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EC number: 279-767-0 | CAS number: 81457-65-0
- 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 substance is virtually nontoxic after a single administration as an aqueous suspension as rats survived application of 10000 mg/kg bw without showing signs of intoxication (Ciba-Geigy Ltd. 1972). Dosing of hamsters with an excessive solution in oil resulted in mortality at 3000, but not at 1000 mg/kg bw (Ciba-Geigy Ltd. 1982).
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: Acceptable study report which meets basic scientific principles (TS purity not provided, 8-day observation period, no GLP).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 8-day observation period
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CFE (RAC, SPF) strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: 126 - 143 g (mean: 135 - 136 g)
- Housing: groups of 5 animals in macrolon cages (size 3)
- Diet (ad libitum): Standard diet of Nafag; ad libitum
- Water (ad libitum): drinking water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day; 10 hours dark/day - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 0.5% CMC in tap water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 and 50% respectively for the low and high dose groups
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw - Doses:
- 5000 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5000 mg/kg bw: 5 male and 5 female animals
10000 mg/kg bw: 3 male and 2 female animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred up to this dose level
- Mortality:
- No mortality.
- Clinical signs:
- other: None observed. Black stained feces were observed in both dose groups.
- Gross pathology:
- No data.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Table 1: Body weights
Dose level (mg/kg bw) |
Mean body weights (g) |
|
Pre-test |
On day 8 of test |
|
5000 |
135 |
194 |
10000 |
136 |
195 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- valid
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
In order to determine the dose/response relationship following the administration of single oral doses of the test material, groups of 3-5 male and 2-5 female rats received by gavage doses of 5000 or 10000 mg/kg bw suspended with 0.5% carboxymethylcellulose and tap water. The total volume given was 20 ml/kg body weight.
Symptoms and mortality after administration were recorded during an observation period of 8 days. Animals excreted black feces. No mortality and no effects on body weight were observed.
The study is valid with restrictions as it was performed prior to the introduction of GLP and had an observation period of 8 instead of 14 days. It should be noted that in the study with hamsters, mortality occurred within the first three days, so the chance of missing a delayed toxicity is low. Considering the excessive doses and the absence of findings, this study is acceptable for the purpose of classification and labeling.
A second study is available in Chinese Hamster. In contrast to the study in rats, peanut oil was used as vehicle. The study followed OECD guideline 401 but was not performed according to GLP. It is described in detail and allows reliable interpretation of the data.
Both males and females were tested and there was no specific sensitivity of one gender. Only unspecific symptoms (dyspnea, exophthalmus, ruffled fur, curved body position) were seen at the dose levels of 300, 1000, 3000 mg/kg bw. The applied volume was 10 or 20 ml per kg bw which exceeds standard requirements for rodents and is excessive particularly for oil as a vehicle. No compound related gross organ changes were observed upon necropsy Mortality occurred only at the dose group of 3000 mg/kg bw and it involved all animals. Death occurred within 5 hours for males and within 5h to three days for females.
The substance is highly soluble in octanol and it is expected that it is well soluble in peanut oil. This may result in a different systemic uptake after ingestion and explain the lower oral toxicity using aqueous carboxymethylcellulose as vehicle.
According to the guidelines, an aqueous vehicle should be considered first. Only as a second choice, oil may be used, but its volume must not exceed 10 ml/kg bw. This has been exceeded in this study and it is possible that this has contributed to the toxicity of the substance.
Overall, the study in rats is chosen as the key study for classification and labeling.
Justification for selection of acute toxicity – oral endpoint
Adequate study and relevant species for classification and labelling.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
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.
A s a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.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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