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EC number: 206-031-8 | CAS number: 292-64-8
- 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
The test item showed low toxicity and the LD50 value was determined to be higher than 2000 mg/kg body weight after single oral administration in female rats (reference 7.2.1-1).
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:
- 2021-10-19 to 2021-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH , Sulzfeld, Germany
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 9 weeks at treatment start
- Weight at study initiation: 175 g (168 – 182 g)
- Fasting period before study: Yes. Diet was withheld from about 17 to 20 hours before start of treatment until 4 hours after administration.
- Housing: During the acclimation phase, the three rats per treatment group were group-housed in type IV Makrolon cages with a shelter on softwood bedding material (ABEDD LTE E-001, ABEDD LAB&VET Service GmbH, Austria). Play tunnels (Ref. 14153, Plexx BV, Netherlands) were placed in the cages as additional enrichment. After treatment, the rats were single housed in type III Makrolon cages with a shelter and a play tunnel on softwood bedding material overnight. One day after treatment the rats were group-housed again in type IV Makrolon cages until the end of the observation period. The bedding was changed once a week.
- Diet: ad libitum, maintenance diet (V1534, ssniff Spezialdiäten GmbH, Germany)
- Water: ad libitum, community water in Makrolon bottles (BIOSCAPE GmbH, Castrop-Rauxel, Germany). Drinking water was changed at least three times per week.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 – 22.9
- Humidity (%): 42.7 – 57.4
- Air changes (per hr): not specified; fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
Not applicable
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the chemical properties of the test item, mortality was not expected at the highest starting dose of 2000 mg/kg bw. Therefore, the treatment was started with 2000 mg/kg bw in three female rats and continued with further three females at 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of treatment, each animal was observed for mortality and for symptoms of intoxication at scheduled intervals according to the record sheets. On the following days, the rats were examined once daily. Symptoms were recorded individually for each animal. All animals were weighed before treatment (day 1) and on day 2, 4, 6, 8, 11, 13 and 15.
- Necropsy of survivors performed: yes - Statistics:
- The study data, mortality , symptoms and body weights were manually recorded on study specific forms. The mean initial body weight was calculated with a packet calculator.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen.
- Clinical signs:
- salivation
- Body weight:
- other body weight observations
- Remarks:
- The body weight gain was lower one day after treatment than usual. One rat showed even a decrease in body on day 2. On the following days there were no effects on the body weight development. For details please refer to "Any other information on results".
- Gross pathology:
- No organ alterations were identified during the gross pathological examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed low toxicity and the LD50 value was determined to be higher than 2000 mg/kg body weight after single oral administration in female rats.
- Executive summary:
The objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was conducted according to OECD TG 423.
The treatment was started with 2000 mg/kg body weight in 3 female rats and continued with further 3 females treated with 2000 mg/kg bw.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
No mortality occurred during the course of this study. All rats treated with 2000 mg /kg bw showed salivation immediately after treatment. Two hours after treatment, salivation was no longer observed. The body weight gain was lower one day after treatment than usual. One rat showed even a decrease in body on day 2. On the following days there were no effects on the body weight development. The gross pathological examination revealed no organ alterations.
The test item showed low toxicity under the conditions of the present study, and the LD50 value is higher than 2000 mg/kg body weight after single oral administration in female rats.
Reference
Animal No. |
Sex |
Dose [mg/kg bw] |
Body weight in g on day | Body weight gain in g | |||||||
1 | 2 | 4 | 6 | 8 | 11 | 13 | 15 | Day 1 to 15 | |||
1 | Female | 2000 | 178 | 179 | 194 | 191 | 203 | 196 | 205 | 208 | +30 |
2 | Female | 2000 | 175 | 179 | 183 | 188 | 194 | 199 | 200 | 205 | +30 |
3 | Female | 2000 | 168 | 169 | 183 | 183 | 185 | 182 | 189 | 190 | +22 |
4 | Female | 2000 | 175 | 176 | 180 | 188 | 196 | 196 | 197 | 203 | +28 |
5 | Female | 2000 | 172 | 172 | 193 | 195 | 197 | 199 | 200 | 204 | +32 |
6 | Female | 2000 | 182 | 181 | 192 | 191 | 200 | 204 | 206 | 212 | +30 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- The guideline study is of sufficient quality to address the endpoint.
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 objective of the present study was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was conducted according to OECD TG 423.
The treatment was started with 2000 mg/kg body weight in 3 female rats and continued with further 3 females treated with 2000 mg/kg bw.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
No mortality occurred during the course of this study. All rats treated with 2000 mg /kg bw showed salivation immediately after treatment. Two hours after treatment, salivation was no longer observed. The body weight gain was lower one day after treatment than usual. One rat showed even a decrease in body on day 2. On the following days there were no effects on the body weight development. The gross pathological examination revealed no organ alterations.
The test item showed low toxicity under the conditions of the present study, and the LD50 value is higher than 2000 mg/kg body weight after single oral administration in female rats.
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. Based on available data on acute toxicity, the test item does not require classification for acute toxicity via the oral route according to Regulation (EC) No 1272/2008 (CLP).
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