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EC number: 475-900-3 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Sept.-06 Oct. 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognised method, and under GLP. The substance is adequately characterised with its purity. Therefore full validation applies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from 2004-08-19
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Details on test material:
- N.B. This batch BWG 60000 was used in several studies with some descriptive information diverging slightly between the reports (for further details, see below in this field and in the following field).
- Appearance:
* Clear yellowish liquid was mentioned in the 2007 and 2008 Notox reports dealing with physico-chemical properties and in the in 2007 Solvay Pharma report dealing with ASRI test.
* Yellow liquid was mentioned in the 2006 and 2007 TNO reports dealing with toxicological endpoints.
- Storage conditions:
* Storage in freezer (=< -15°C) in the dark under nitrogen was mentioned in the 2007 and 2008 Notox reports dealing with physico-chemical properties.
* Storage in freezer (< -10°C) was mentioned in the 2007 Solvay Pharma report dealing with ASRI test.
* Storage at < -18°C (with or without the mention "protected from light") was mentioned in the 2006 and 2007 TNO reports dealing with toxicological endpoints.
- Stability under storage conditions: Stable.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wistar outbred rat; Crl:(WI) WU BR obtained from Charles River, Germany.
- Females nulliparous and non-pregnant: Not specified in the report.
- Age at arrival: 7-8 weeks.
- Weight at study initiation: 154-172 g.
- Fasting period before study: Prior to dosing, the animals has fasted overnight. Approximately 4 hours after dosing, they had access to food again.
- Housing: A maximum of 6 animals per macrolon cage.
- Diet: Standard laboratory diet ad libitum. Each batch of this diet was analysed by the supplier (SDS Special Diets Services, Whitham, England) for the nutrients and contaminants and the results were kept available in the archives.
- Water: Tap water (N.V. Hydron Midden-Nederland) ad libitum .
- Acclimation period: 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 40-70%. Upper limit occasionally up to 100%, because of wet cleaning of the animal room.
- Air changes: ca. 10 air changes/hour.
- Photoperiod: 12 hours light / 12 hours dark cycle.
IN-LIFE DATES:
- Start of study: 19/09/2006 (first group at 300 mg/kg and group at 2000 mg/kg) and 22/09/2006 (second group at 300 mg/kg).
- Termination of study: 06/10/2006.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- DOSING
The animals were dosed with a 10 mL/kg body weight of a 30 or 200 mg/mL dilution of the test substance in maize oil in order to obtain the 300 and 2000 mg/kg bwt. The exact amount of the test substance to be dosed was calculated for each animal individually and administered by means of a syringe, equipped with an oral gavage.
CLASS METHOD
Rationale for the selection of the starting dose: The study was started with a dose level of 300 mg/kg body weight; which is the starting dose recommended in OECD 423 guideline when there is no information on the test substance. - Doses:
- 300 and 2000 mg/kg bwt.
- No. of animals per sex per dose:
- 300 mg/kg bwt: 2 groups of 3 females; one being tested at the start of the study and the other being tested after having observed mortality in the 2000 mg/kg bwt dose level group.
2000 mg/kg bwt: 1 group of 3 females. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: All visible reactions to treatment were recorded, including type, severity, onset and duration. Observations were made within 1 hour and within 4 hours after dosing, and subsequently in surviving animals at least once daily throughout an observation period of 14 days. The body weight of each animal was recorded immediately before dosing on day 0, and on days 3, 7 and 14 of the study for the surviving animals.
- Necropsy of survivors performed: at the end of the observation period (on day 14), all surviving animals were killed with carbon dioxide and examined for external changes. Next, the abdominal and the thorax of each animal was opened and examined for gross pathological changes. - Statistics:
- No
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bwt: All animals survived.
2000 mg/kg bwt: All animals died. - Clinical signs:
- 300 mg/kg bwt: No clinical signs, other than transient piloerection in the first three animals dosed, were observed during the 14-day study period.
2000 mg/kg bwt: The animals generally showed sluggishness, blepharospasm, stretching, piloerection and increased respiratory frequency prior to their death. - Body weight:
- 300 mg/kg bwt: All animals gained weight during the 14-day study:
* Day 0: mean weight = 163 and 161 g for the first and second groups, respectively.
* Day 3: mean weight = 179 and 178 g for the first and second groups, respectively.
* Day 7: mean weight = 184 and 191 g for the first and second groups, respectively.
* Day 14: mean weight = 197 g for both groups.
2000 mg/kg bwt: All animals died within 24 hours after dosing:
* Day 0: mean weight = 160 g. - Gross pathology:
- Examination at necropsy of the animals did not reveal distinct treatment-related gross alterations, other than one animal of the 2000 mg/kg bwt dose level which showed a stomach filled with liquid.
Any other information on results incl. tables
Body weight, mortality and clinical signs:
|
Body weight (g) |
Mortality |
Clinical signs |
|||
Day 0 |
Day 3 |
Day 7 |
Day 14 |
|||
300 mg/kg bwt – 1st group |
||||||
1st animal |
160 |
177 |
182 |
193 |
Alive |
Transient piloerection (1h) in the three animals |
2nd animal |
158 |
174 |
178 |
192 |
Alive |
|
3rd animal |
172 |
187 |
191 |
207 |
Alive |
|
300 mg/kg bwt – 2nd group |
||||||
1st animal |
155 |
175 |
185 |
195 |
Alive |
No clinical sign |
2nd animal |
163 |
180 |
197 |
202 |
Alive |
|
3rd animal |
165 |
180 |
190 |
193 |
Alive |
|
2000 mg/kg bwt |
||||||
1st animal |
166 |
Found dead on day 1; terminal weight = 162 |
Dead |
Sluggishness, stretched body position, blepharospasm, piloerection, increased respiratory frequency in 3 animals Coldness in 1 animal |
||
2nd animal |
161 |
Found dead on day 0; terminal weight = 160 |
Dead |
|||
3rd animal |
154 |
Found dead on day 1; terminal weight = 166 |
Dead |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 of ETFBO was determined to be between 300 and 2000 mg/kg bwt in female Wistar rats.
- Executive summary:
The acute oral toxicity to female Wistar rats was investigated in a GPL-compliant study performed according to OECD test guideline 423 (acute toxic class method).
Two ETFBO dose levels were tested: 300 and 2000 mg/kg bwt. Two groups of three females were treated with the dose level of 300 mg/kg bwt, and one group of 3 females was treated with the dose level of 2000 mg/kg bwt. Route of administration was oral gavage using maize oil as vehicle. The observation period lasted 14 days following administration. All visible reactions to treatment were recorded, including type, severity, onset and duration. Observations were made within 1 hour and within 4 hours after dosing, and subsequently in surviving animals at least once daily throughout an observation period of 14 days. The body weight of each animal was recorded immediately before dosing on day 0, and on days 3, 7 and 14 of the study for the surviving animals. At the end of the observation period (on day 14), all surviving animals were killed with carbon dioxide and examined for external changes. Next, the abdominal and the thorax of each animal was opened and examined for gross pathological changes.
At the dose level of 300 mg/kg bwt, all animals survived, gained weight during the 14-day study and no clinical signs, other than transient piloerection in the first three animals dosed, were observed. At the dose level of 2000 mg/kg bwt, all animals died within 24 hours after dosing and generally showed the following clinical signs prior to their death: sluggishness, blepharospasm, stretching, piloerection and increased respiratory frequency. Examination at necropsy of the animals did not reveal distinct treatment-related gross alterations, other than one animal of the 2000 mg/kg bwt dose level which showed a stomach filled with liquid.
Under the conditions of this study, the acute oral LD50 value of ETFBO was thus determined to be between 300 and 2000 mg/kg bwt. According to the GHS criteria, ETFBO has to be considered as harmful if swallowed and has to be classified in category 4 for acute oral toxicity.
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