Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
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:
- From 26 February, 2020 to 12 March, 2020
- 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)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Directive 96/54/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Sprague-Dawley derived, albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals
Number of Animals: 3
Sex: Female, nulliparous and non-pregnant.
Species/Strain: Rat/Sprague-Dawley derived, albino.
Age/Body Weight: Young adult (10 weeks)/213-221 grams at experimental start.
Source: Received from Charles River Laboratories on February 6, 2020.
Husbandry
Housing: The animals were housed in caging which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Animals were group housed, except on the day of administration, at which time they were single housed and until the animals were deemed acceptable, based on observations, to return to group housing. Enrichment (e.g., toy) was placed in each cage and litter was changed at least once per week.
Animal Room Temperature and Relative Humidity Ranges: 20-24ºC and 42-56%, respectively.
Animal Room Air Changes/Hour: 12. Airflow measurements are evaluated regularly and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 20 or 21 days
Food: Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during fasting.
Water: Filtered tap water was supplied ad libitum.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file at Product Safety Labs.
Identification
Cage: Each cage was identified with a cage card indicating at least the study number, dose level, identification, and sex of the animal.
Animal: A number was allocated to each rat on receipt and a stainless steel ear tag bearing this number was attached to the rat. This number, together with a sequential animal number assigned to study number 52369, constituted unique identification. Only the sequential animal number is presented in this report. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The prepared test mixture was administered to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing.
- Doses:
- 5000 mg/kg bw limit dose
- No. of animals per sex per dose:
- 3 female rats
- Control animals:
- no
- Details on study design:
- Procedure
Selection of Animals
Prior to each dosing, experimentally naive rats were fasted overnight by removing the feed from their cages. During the fasting period, the rats were examined for health and weighed (initial). Three healthy, naive female rats (not previously tested) were selected for test.
Preparation of Test Substance
The test substance, as received, was a solid. The test substance was administered as a 40% w/w mixture in distilled water. Preliminary sample preparation assessments conducted by PSL indicated that mixtures in excess of 40% (i.e., 50-80%) were too viscous to be administered properly. Each preparation was mixed well prior to use.
Dose Calculations
Individual doses were calculated based on the initial body weights, taking into account the density (determined by PSL) and concentration of the test mixture.
Dosing
The prepared test mixture was administered to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing. An initial limit dose of 5000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional females received the same dose level, simultaneously.
In-life Observations
The animals were observed for mortality, signs of gross toxicity, and behavioral changes approximately 30 minutes post-dosing, during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
Body Weights
Individual body weights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (terminal) following dosing.
Necropsy
All rats were euthanized via CO2 inhalation at the end of the 14-day observation period. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- Statistical analysis was limited to the calculation of the mean density value for dosing.
- Preliminary study:
- All animals survived test substance administration, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, adverse clinical effects, or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Mortality:
- No mortality observed
- Clinical signs:
- There were no signs of gross toxicity, adverse clinical effects, or abnormal behavior.
- Body weight:
- All animals survived test substance administration, gained body weight, and appeared active and healthy during the study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the acute oral LD50 of the test substance was determined to be >5000 mg/kg bw in female rats.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance in rats according to OECD Guideline 423 and EU Method B.1 tris, in compliance with GLP. Initially, a limit dose of 5000 mg/kg bw was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional females received the same dose level, simultaneously. Since these animals survived, no additional animals were tested. All animals were observed for mortality, signs of gross toxicity and behavioural changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration (initial) and again on Days 7 and 14. Necropsies were performed on all animals at terminal sacrifice. All animals survived test substance administration, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, adverse clinical effects or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied. Under the study conditions, the acute oral LD50 of the test substance was determined to be >5000 mg/kg bw in female rats (Durando, 2020).
Reference
Table 1: Individual body weight
Animal No. |
Sex |
Dose Level (mg/kg) |
Body Weight (g) |
Dose* |
||
Initial |
Day 7 |
Day 14 |
mL |
|||
3101 |
F |
5000 |
214 |
236 |
265 |
2.5 |
3102 |
F |
213 |
246 |
265 |
2.5 |
|
3103 |
F |
221 |
250 |
280 |
2.6 |
*The test substance was administered as a 40% w/w mixture in distilled water. Density –1.06g/mL
Table 2: In-life observations
Animal Number |
Animal Sex |
Dose Level (mg/kg) |
Observation |
Day of Observation (x=observation is present) |
|||||||||||||||
0(0.5 hr) |
0(3 hrs) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||
3101 |
F |
5000 |
Active and healthy |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|||||||||||||||||||
3102 |
F |
5000 |
Active and healthy |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|||||||||||||||||||
3103 |
F |
5000 |
Active and healthy |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
Table 3: Necropsy observation
Animal Number |
Animal Sex |
Dose Level (mg/kg) |
Organ / Tissue |
Observation |
3101 |
F |
5000 |
All tissues and organs |
No gross abnormalities |
|
||||
3102 |
F |
5000 |
All tissues and organs |
No gross abnormalities |
|
||||
3103 |
F |
5000 |
All tissues and organs |
No gross abnormalities |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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
A study was conducted to determine the acute oral toxicity of the test substance in rats according to OECD Guideline 423 and EU Method B.1 tris, in compliance with GLP. Initially, a limit dose of 5000 mg/kg bw was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, two additional females received the same dose level, simultaneously. Since these animals survived, no additional animals were tested. All animals were observed for mortality, signs of gross toxicity and behavioural changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration (initial) and again on Days 7 and 14. Necropsies were performed on all animals at terminal sacrifice. All animals survived test substance administration, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, adverse clinical effects or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied. Under the study conditions, the acute oral LD50 of the test substance was determined to be >5000 mg/kg bw in female rats (Durando, 2020).
Justification for classification or non-classification
Based on an acute oral toxicity study in rats, no classification is warranted according to EU CLP (Regulation EC/1272/2008) criteria.
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.
