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EC number: - | 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
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
- Acute oral toxicity [OECD 423, acute toxic class method; GLP]: LD50 in female rats >2000 mg/kg bw.
- Acute inhalation toxicity: Taking into account the very low vapour pressure of the registration substance, exposure via the inhalation route is unlikely; it is therefore considered justified to omit this endpoint information.
- Acute dermal toxicity [OECD 402, standard acute method; GLP]: LD50 in male/female rats >2000 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
- 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:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, Boîte postale 0109, 69592 L’ARBRESLE , France
- Age at study initiation: 8 and 12 weeks
- Weight at study initiation: 150 and 250 g
- Fasting period before study: yes (approx. 12h)
- Housing: transparent polycarbonate (macrolone type III) cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1000 mg per mL
MAXIMUM DOSE VOLUME APPLIED: 2 mL per kg of body weight per animal
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no toxicity expected - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily/ 3 times per week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Behaviour, impact on RS or CNS
- Body weight:
- other body weight observations
- Remarks:
- The body weight gain per day was calculated for each animal, as well as the average of the body weight gain per day for each study group. Averages of body weight gain per day are: for group 1 (2000 mg/kg CARDOLITE NC-513): 3.2 g/day for group 2 (2000 mg/kg CARDOLITE NC-513): 0.6 g/day The comparison to published results in literature as well as to the results obtained in other studies performed by the laboratory revealed that growth of all animals of the study group 1 is in the same range than growth of normally untreated SD (Sprague Dawley) rats, in contrary of the growth of the animals for the group 2. Weight gain for the group 1 is about five times higher than in group 2. Furthermore, a weight loss peak was recorded for each group approximately at the same time: from day 8 to day 11 for both groups. Nevertheless, this weight loss is more remarkable in group 2 than in group 1
- Gross pathology:
- No abnormalities were recorded during the macroscopic examination.
- Other findings:
- Oral gavage at dose level of 2000 mg per kg body weight of the test item, CARDOLITE NC-513, may influence the food consumption and may have an impact on the appetite.
- Interpretation of results:
- other:
- Remarks:
- EU GHS criteria not met
- Conclusions:
- In a GLP-study according to OECD Test Guideline 423, the acute oral LD50 of the registered substance was determined to be > 2000 mg/kg bw.
- Executive summary:
The results obtained in a GLP-study according to OECD Test Guideline 423 indicate that a single administration of CARDOLITE NC-513 at 2000 mg/kg on female rats did not result in behavior changes. No clinical signs were detected during the study.
However CARDOLITE NC-513 had an influence on food consumption and on weight gain especially in group 2.
Due to the low number of animals no statistical analysis was performed.
In consequence no statistical difference could be highlighted.
Some differences were observed between both groups despite the fact that both groups were injected with the same dose of CARDOLITE NC-513 (2000 mg/kg) using the same conditions of injection,
In conclusion oral gavage at dose level of 2000 mg per kg body weightof the test item, CARDOLITE NC-513, may influence the food consumption and may have an impact on the appetite, but has no lethal effect on animals.
The LD50 cut off of the test item CARDOLITE NC-513 is higher than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Reliable GLP study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- some minor deviations (no impact)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, Boîte postale 0109, 69592 L’ARBRESLE , France
- Age at study initiation: no information
- Weight at study initiation: 200 - 300 g
- Fasting period before study: no
- Housing: transparent polycarbonate (macrolone type III) cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- other: One day after the application coordination was impacted during a period of one day. Skin from almost all animals was affected: desquamation, small wounds, and skin irritation
- Body weight:
- other body weight observations
- Remarks:
- reduced female body weight gain due to reduced food consumption
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- In a GLP-study according to OECD Test Guideline 402 conducted as a limit test, the acute dermal LD50 of the registered substance was determined to be > 2000 mg/kg bw.
- Executive summary:
The results of a limit test according to OECD Test Guideline 402 indicate that a single dermal application of CARDOLITE NC-513 at 2000 mg/kg on female and male rats did not result in major behavior changes. One day after the application coordination was impacted during a period of one day but no other clinical signs were detected during the study. Some reversible effects on skin such as desquamation, small wounds, and skin irritation were observed. Kidney abnormalities (such as hemorrhagic stain) for male and female were recorded during the macroscopic examination after necropsy. CARDOLITE NC-513 had an influence on food consumption and on weight gain for
female In conclusion dermal application at dose level of 2000 mg per kg body weight of the test item, CARDOLITE NC-513, may influence the food consumption and may have an impact on the appetite for female.
In conclusion the LD50 of the test item CARDOLITE NC-513 is higher than 2000 mg/kg body weight by dermal route in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Reliable GLP study
Additional information
No mortality was observed in an acute oral and an acute dermal toxicity study up to the limit test concentration of 2000 mg/kg bw.
Justification for classification or non-classification
On the basis of the available acute toxicity data via the oral and dermal route, the registration substance does not require classification for lethal effects following a single exposure according to Regulation 1272/2008/EC.
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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