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EC number: 477-470-2 | 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
In an acute oral toxicity study according to OECD guideline 423 (acute oral toxicity - acute toxic class method), the LD50 was >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:
- 2007-10-10 to 2007-11-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdRccHan : WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not specified
- Weight at study initiation: 152 - 204 g
- Fasting period before study: overnight, after administration of the test item the food was withheld for for further 3- 4 h
- Housing: Macrolon cages on Altromin saw fiber bedding
- Diet (ad libitum): Altromin 1324 maintanenance diet for rats and mice, specific pathogen-free
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Microbiological status: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: non-toxic characteristics
- Amount of vehicle: 10 mL
- Lot no.: 066K0057
MAXIMUM DOSE VOLUME APPLIED: 10 mL - Doses:
- 300 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to treatment and once a week thereafter
- Necropsy of survivors performed: yes
- Clinical signs: yes, several times on the day of dosing and once a day thereafter
- Other examinations performed: no - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: No treatment related effect was observed in any animal of any step.
- Gross pathology:
- Effects on organs: No treatment realated effect was observed in any animal of any step.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this toxicity test it can be stated that the test item Beta 30 showed no orally toxic characteristics, the LD50 was >2000 mg/kg bw.
- Executive summary:
The acute toxic class method according to OECD 423 was performed with the test item Beta 30. In the first and second step, the test item was given at a dose of 300 mg/kg bw to a group of 3 female rats (HsdRccHan : WIST) via gavage. No compound related mortality was recorded for any of the treated animals in step 1 and 2. Based on these results and in accordance with the acute toxic class regime, the third and fourth steps of the test were performed with 2000 mg/kg bw with further groups of 3 female rats. No compound related mortality was observed in step 3 and 4. A clinical examination did not reveal any signs of toxicity in any animal and test step. Further, no treatment related gross pathological changes were found in any animal and test step. Throughout the 14-days observation period, no weight loss was recorded for any animal. The weight gain was within the expected range.
The test item Beta 30 was concluded to show no oral toxicity, the LD50 was >2000 mg/kg bw.
Reference
Table 1: Absolute body weights in g
Animal No./ Sex | Day 0 | Day 7 | Day 14 |
Step 1 (300 mg/kg bw) | |||
1/ female | 152 | 190 | 193 |
2/ female | 194 | 205 | 210 |
3/ female | 204 | 230 | 239 |
Step 2 (300 mg/kg bw) | |||
1/ female | 168 | 204 | 200 |
2/ female | 165 | 193 | 194 |
3/ female | 160 | 185 | 200 |
Step 3 (2000 mg/kg bw) | |||
1/ female | 170 | 197 | 200 |
2/ female | 160 | 185 | 199 |
3/ female | 167 | 194 | 194 |
Step 4 (2000 mg/kg bw) | |||
1/ female | 168 | 178 | 182 |
2/ female | 180 | 200 | 202 |
3/ female | 172 | 191 | 193 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 1
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
Acute oral toxicity
The acute toxic class method according to OECD 423 was performed with the test item. In the first and second step, the test item was given at a dose of 300 mg/kg bw to a group of 3 female rats (HsdRccHan : WIST) via gavage. No compound related mortality was recorded for any of the treated animals in step 1 and 2. Based on these results and in accordance with the acute toxic class regime, the third and fourth steps of the test were performed with 2000 mg/kg bw with further groups of 3 female rats. No compound related mortality was observed in step 3 and 4. A clinical examination did not reveal any signs of toxicity in any animal and test step. Further, no treatment related gross pathological changes were found in any animal and test step. Throughout the 14-days observation period, no weight loss was recorded for any animal. The weight gain was within the expected range.
The test item was concluded to show no oral toxicity, the LD50 was >2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
Oral toxicity
Based on available data on acute toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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