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Diss Factsheets
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EC number: 946-911-5 | 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
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Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), rat: LD50 cut-off 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
- Study period:
- 15 Nov - 12 Dec 2016
- 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:
- adopted 17 Dec 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 180.2 - 219.3 g
- Fasting period before study: Animals were fasted overnight approx. 16 h prior to dosing and 4 h post dosing.
- Housing: individually in stainless wire mesh cages (260W×350D×210H mm)
- Diet: Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), ad libitum
- Water: public tap water filtered and irradiated by UV-light, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 - 24.6
- Humidity (%): 47.0 - 61.7
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 and 60 mg/mL
- Amount of vehicle: 5 mL/kg bw
- Lot/batch no.: MKBV2080V, MKBW9504V
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, 2,000 mg/kg was selected as the starting dose for this study based on the information supplied by the sponsor. - Doses:
- 2000 mg/kg bw (step 1 and 2), 300 mg/kg bw (step 3 and 4)
- 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: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Mean scores and values were determined.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg bw: 0/3 animals (step 1) and 2/3 animals (step 2) at Day 4
300 mg/kg bw: 0/3 animals (step 3) and 0/3 animals (step 4) - Clinical signs:
- 2000 mg/kg bw: In surviving animals abnormal gait was observed in four animals at 0.5 - 6 h after dosing, and a decrease of fecal volume was observed in four animals on Day 1, fully reversible 48 h. In dead animals abnormal gait was observed in two animals at 0.5 - 4 h after dosing, and lacrimation, loss of locomotor activity and lying on side were observed in two animals at 6 h after dosing to Day 3 and additional signs as no stool and refusal to feed from Day 1 to Day 3. Then, these animals were found dead in a state of lying on side on Day 4.
300 mg/kg bw: No abnormalities of clinical signs were observed in any animal throughout the study. - Body weight:
- 2000 mg/kg bw: In surviving animals a tendency for suppression of body weight gain was observed in one animal on Day 1. Then, normal body weight gain was observed in these animals on Day 3. In dead animals, a decrease in body weight was observed in two animals on Day 1 and Day 3.
300 mg/kg bw: Body weight gains were within the normal ranges during the whole study period. - Gross pathology:
- No grossly visible findings were observed in any animal at 300 and 2000 mg/kg.
- Interpretation of results:
- other: Acute Tox. Cat. 4 according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in female rats a LD50 cut-off value of 2000 mg/kg bw was found.
- Executive summary:
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2017). In step 1, the test substance was administered via oral gavage to 3 female rats at dose level of 2000 mg/kg bw. Since no mortality occurred, 2000 mg/kg bw was administered to 3 further animals in a second step. Two animals were found dead on Day 4 after administration. Therefore, 300 mg/kg bw was administered to 3 animals each in step 3 and 4. No mortality was observed at 300 mg/kg bw. Based on the results a LD50 cut-off of 2000 mg/kg bw was determined in this study.
Reference
Table 1. Results of the acute oral toxicity study.
Dose level (mg/kg bw) |
Mortalities |
Clinical signs |
|
n |
|
2000 (step 1) |
0/3 |
3/3 |
2000 (step 2) |
2/3 |
3/3 |
300 (step 3) |
0/3 |
0/3 |
300 (step 4) |
0/3 |
0/3 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
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
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2017). In step 1, the test substance was administered via oral gavage to 3 female rats at dose level of 2000 mg/kg bw. Since no mortality occurred, 2000 mg/kg bw was administered to 3 further animals in a second step. Two animals were found dead on Day 4 after administration. Therefore, 300 mg/kg bw was administered to 3 animals each in step 3 and 4. No mortality was observed at 300 mg/kg bw. Based on the results a LD50 cut-off of 2000 mg/kg bw was determined in this study.
Justification for classification or non-classification
The available data on acute oral toxicity meet the criteria for classification as Acute Tox. 4 (H302) according to Regulation (EC) 1272/2008.
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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