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EC number: 942-293-6 | CAS number: -
- 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
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
LD0 > 250 mg/kg
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:
- Start of experiment: 2012-03-28; End of experiment (last necropsy): 2012-05-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- For the dose-range finding puspose, the rats were treated for seven days at doses of up to 1000 mg/kg bw.
Although the study design does not correspond to any of the current study guideline for acute oral toxicity assessment, the obtained result is considered to be sufficiently evident for a reilable acute oral toxicity assessment. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: 7-day repeated dose toxicity study
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:WI rats
Source: Charles River Laboratories, Germany GmbH, Sandhofer Weg 7, D-97633
Hygienic level: SPF at the supplier, standard laboratory conditions during the study
Number of animals: 8 male and 8 female rats
Age of animals: Young adult virgin rats, 10-11 weeks at starting; the
age range within the study was kept to the minimum
practicable.
Body weight: Did not exceed ± 20% of the mean weight for each
sex at onset of treatment: 369-399 g (males) and 249-269 g (females)
Acclimation period: At least 5 days (staggered treatment) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 0, 62.5, 250 and 1000 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 250 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no significant toxicity within seven days of repeated dose; the dose level of 250 mg/kg bw can be safely regarded as LD0
- Sex:
- male/female
- Dose descriptor:
- LD100
- Effect level:
- < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: the animals died after second or third application at daily dose of 1000 mg/kg bw; the LD100 should be regarded as < 2000 mg/kg bw
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral acute toxicity is derived based on the findings in the seven days repeated dose toxicity study. The LD50 is assessed to be in the range of harmful upon ingestion.
With respect to the classification and labelling according to GHS, the Acute Tox.4 should be assigned.
With respect to the classification and labelling according to 67/548/EEC (DSD), Xn; R22 should be assigned. - Executive summary:
For the dose-range finding puspose, the rats were treated for seven days at doses of up to 1000 mg/kg bw.
Although the study design does not correspond to any of the current study guideline for acute oral toxicity assessment, the obtained result is considered to be sufficiently evident for a reilable acute oral toxicity assessment.
All animals treated at daily dose of 1000 mg/kg bw died after second or third application, whereas all animals treated at daily dose of 250 mg/kg bw survied the scheduled applicaiton of seven days.
Based on those findings, the test item can reliably be considered as harmful upon ingestion.
With respect to the classification and labelling according to GHS, the Acute Tox.4 should be assigned.
With respect to the classification and labelling according to 67/548/EEC (DSD), Xn; R22 should be assigned.
Reference
Study results
At daily dose of 1000 mg/kg bw all animals (two males and two females) died after second or third application. The clinical signs observed prior to death included decreased activity, gasping respiration, salivation, piloerection, lethargy, hunched back and lacrimation. These animals exhibited severe body weight loss prior to death. At necropsy evaluation, the findings in dead animals were dark/red discoloratioin of the enlarged lungs, white foamy material in the trachea, enlarged adrenals, dark/red discoloration/focus on the thymus or glandular/non glandular stomach, mucoid material mixed with diet within the stomach, yellow/brown mucoid material in the digestive content of the duodenum, jejunum, ileum, cecum, colon and/or rectum. Additionally, clear liquid material at the perioral/periorbital area and/or red discoloration of the periorbital/perinasal area and yellow/brown discoloured nerinasal area, were also found.
At daily dose of 250 mg/kg bw all animals (two males and two females) survived the seven days application. One female exhibited sneezing, gasping respiration, piloerection, noisy respiration, salivation, decreased activity and incoordinated movement and one male exhibited increased respiration. In addition, reduced body weight gain and reduced food consumption were found, whereas the effect was more pronounced in the first three days. At necropsy at the end of the observation period, thickened/rough surface non glandular mucosa of the stomach was found in 3/4 rats.
At daily dose of 62.5 mg/kg bw all animals (two males and two females) survived the seven days application. The clinical signs observed were limited to noisy respiration in one female and increase respiration rate in one male. The body weight gain and the food consumption were also slightly affected.
Tab: Body weight development [g]; individual values and mean |
|||||||
Dose group |
|
Males |
Females |
||||
Day 0 |
Day 3 |
Day 6 |
Day 0 |
Day 3 |
Day 6 |
||
Control |
Value 1 |
369 |
382 |
393 |
265 |
265 |
273 |
Value 2 |
398 |
408 |
433 |
253 |
246 |
248 |
|
Mean |
384 |
395 |
413 |
259 |
256 |
261 |
|
62.5 mg/kg bw/day |
Value 1 |
392 |
408 |
411 |
259 |
243 |
244 |
Value 2 |
375 |
368 |
375 |
249 |
249 |
255 |
|
Mean |
384 |
388 |
393 |
254 |
246 |
250 |
|
250 mg/kg bw |
Value 1 |
377 |
337 |
343 |
251 |
235 |
241 |
Value 2 |
399 |
389 |
400 |
265 |
222 |
194 |
|
Mean |
388 |
363 |
372 |
258 |
229 |
218 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 250 mg/kg bw
- Quality of whole database:
- One key study and two supporting experiments; consistent results were obtained
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
Acute oral toxicity
For the dose-range finding puspose, the rats were treated with registration substance for seven days at doses of up to 1000 mg/kg bw.
Although the study design does not correspond to any of the current study guideline for acute oral toxicity assessment, the obtained result is considered to be sufficiently evident for a reilable acute oral toxicity assessment.
All animals treated at daily dose of 1000 mg/kg bw died after second or third application, whereas all animals treated at daily dose of 250 mg/kg bw survied the scheduled applicaiton of seven days.
Based on those findings, the registration substance can reliably be considered as harmful upon ingestion.
With respect to the classification and labelling according to GHS, the Acute Tox.4 should be assigned.
Justification for selection of acute toxicity – oral endpoint
Scientifically well-performed study
Justification for classification or non-classification
Based on the experimental result, the registration substance can reliably be considered as harmful upon ingestion.
With respect to the classification and labelling according to GHS, the Acute Tox.4 should be assigned.
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