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Diss Factsheets
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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
![](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:
- Aug - Oct 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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
Test material
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material:
Clariant Plastics and Coatings (Deutschland) GmbH,
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Invivo Biosciences, Shed No. 23, Katha No.3169, Assessment No. 154, Kodigehalli Village, Magadi Road, Bangalore-560091, Karnataka, India
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 10 to 12 Weeks
- Weight at study initiation: 182.0 to 228.6 g
- Housing: Rats were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage once a week.
Bedding: steam sterilized corn cob was used and changed once a week along with the cage.
- Diet (e.g. ad libitum): Hypro Rat & Mice pellet feed, manufactured by Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharashtra, was provided to animals.
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, was provided to animals in polycarbonate bottles with stainless steel sipper tubes.
- Acclimation period: G1 (FTS) 8-Aug to 13-Aug 2018; G1 (STS) 8-Aug to 15-Aug 2018
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 65 to 67%
- Air changes (per hr): 12.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle
IN-LIFE DATES: G1 (FTS) From: 14-Aug 2018 To: 28-Aug 2018
G1 (STS) From: 16-Aug 2018 To: 30-Aug 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The corn oil is commonly used for toxicological studies in our laboratory and was found to be non-toxic in several animal species upon single and repeat dose administration.
- Lot/batch no. (if required): MKCD1021
MAXIMUM DOSE VOLUME APPLIED: 10 mL per kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg body weight - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 animals (females) / treatment step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days post dosing
- Frequency of observations and weighing: At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15. Body weight on day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: There were no clinical signs and pre-terminal deaths.
- Gross pathology:
- There were no gross pathological changes at necropsy
Any other information on results incl. tables
TABLE 1. Individual body weight, body weight changes and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Body weight (g) |
No. dead/ No. tested |
Pre-terminal deaths (%) |
||||
Initial (Day 1) |
8thday |
Weight change (day 8 – Initial) |
15thday |
Weight change (day 15 – Initial) |
|||||
G1 (FTS) 2000 |
Rw901 |
F |
228.6 |
235.9 |
7.3 |
242.6 |
14.0 |
0/3
|
0 |
Rw902 |
F |
196.8 |
201.3 |
4.5 |
209.5 |
12.7 |
|||
Rw903 |
F |
182.0 |
188.4 |
6.4 |
193.9 |
11.9 |
|||
G1 (STS) 2000 |
Rw904 |
F |
190.5 |
196.2 |
5.7 |
204.8 |
14.3 |
0/3
|
0 |
Rw905 |
F |
202.9 |
209.7 |
6.8 |
217.1 |
14.2 |
|||
Rw906 |
F |
221.8 |
226.9 |
5.1 |
233.0 |
11.2 |
F: Female FTS: First Treatment Step STS: Second Treatment Step
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, the acute oral LD50 cut-off value is 5000 mg/kg body weight or "unclassified" for the test item,
Licocare RBW300 FL TP. - Executive summary:
The acute oral toxicity study with Licocare RBW 300 FL TP in Wistar rats was conducted to assess the toxicological profile of the test item. The dose formulation was prepared by using corn oil and administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at a dose volume of 10 mL/kg body weight to attain the dose of 2000 mg/kg body weight. There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, three additional female rats were tested at the same dose of 2000 mg/kg body weight (G1-STS). There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, no further test was needed, hence, the dosing was stopped.
The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing and again on days 8 and 15. Necropsy was performed for all the surviving rats at terminal sacrifice. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.
Based on the results of the present study, the acute oral LD50cut-off value is 5000 mg/kg body weight or ∞ (unclassified) for the test item.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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