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EC number: 813-271-2 | CAS number: 439661-46-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November - December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- - State of aggregation: Non-aggregated
- Particle size distribution: D50 = 12.2 µm
- Geometric standard deviation (GSD): 0.2
- Shape of particles: not assessed
- Surface area of particles: not determined
- Crystal structure: Crystalline, no further details known
- Coating: None
- Moisture content: 0.03%
- Residual solvent: Non detected
- Activation: Not applicable
- Stabilisation: With Phenothiazine (< 1000 ppm)
- Other:
Constituent 1
- Specific details on test material used for the study:
- Test Item ROC-601
Lot Number S23PSG0816
CAS No 439661-46-8
Purity 99.5% by LC-UV
Appearance White crystalline powder
Composition 99.5%
Homogeneity Uniform crystalline powder
Production Date 29 June 2016
Expiry Date July 2017
Storage Room Temperature (20 ± 5 °C), keep away from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Wistar rats
Source: Dobrá Voda, Slovak Republic
Number and Sex of Animals: 6 females
Age at First Dose: 8 - 12 weeks; female animals were non-pregnant and nulliparous
Animal Health: The health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22.1 ± 0.3 °C, relative humidity within 56.3 ± 2.5 %. The light regime was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures.
Diet: A laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered in recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
Water: The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodically analysed (including microbiological control) and recorded; a certificate of analysis is included in raw data.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- The test item 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 item was administered. After the test item had been administered, food was withheld for a further 3 - 4 hours.
- Doses:
- According to OECD TG 423 the starting dose is to be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. Therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose. The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration.
- No. of animals per sex per dose:
- 3 females in initial test and 3 females in verification test, in total 6 females
- Control animals:
- no
- Details on study design:
- Observation: The animals were observed individually immediately after the administration of the test item and then 0.5, 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.
Body Weights: Individual weights of animals were determined shortly before the test item was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
Necropsy: All test animals were subjected to gross necropsy and result were recorded for each animal. - Statistics:
- None applied in lack of effects
Results and discussion
Effect levels
- Key result
- Sex:
- 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
- Remarks:
- No mortality was observed during the study.
- Mortality:
- No mortality was observed during the study. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
- Clinical signs:
- No clinical signs were obersed in any of the 6 female rats investigated
- Body weight:
- The body weights of 5/6 animals increased during the study. Stagnation of the body weight in 3 animals and mild increase of the body weight in the rest animals was observed between first and second week after administration.
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic findings were noticed.
- Other findings:
- None
Any other information on results incl. tables
Clinical Observations overview:
Observation |
Time After Administration |
||||||||||||||||||
Hour |
Day |
||||||||||||||||||
Immediately |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Skin and Hair |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- mean "No observed signs"
Body weights
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
200 |
200 |
200 |
0 |
0 |
0 |
2 |
200 |
210 |
215 |
10 |
15 |
5 |
||
3 |
180 |
195 |
210 |
15 |
30 |
15 |
||
4 |
175 |
195 |
195 |
20 |
20 |
0 |
||
5 |
185 |
200 |
200 |
15 |
15 |
0 |
||
6 |
165 |
190 |
195 |
25 |
30 |
5 |
Necropsy results:
Sex |
Dose |
ID |
Result |
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
no finding |
♀ |
2000 mg/kg |
4 |
no finding |
2 |
no finding |
5 |
no finding |
||||
3 |
no finding |
6 |
no finding |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item ROC-601 is higher than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure of OECD Guideline 423 with a Starting Dose of 2000 mg/kg body weight, and recognizing no mortality or adverse effects in any of the animals used at that dose (0/6 moribund or dead animals), it can be concluded that the test item ROC-601 is unclassified according to GHS with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. - Executive summary:
The test item ROC-601 administered to 6 females at limit dose of 2000 mg/kg body weight did not cause death. Stagnation of the body weight in 3 animals and mild increase of the body weight in the rest animals was observed between first and second week after administration. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours in females or 14 -day observation period. During necropsy, no macroscopic findings were noticed.
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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