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EC number: 279-899-9 | CAS number: 82089-64-3
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-03-2017 to 29-03-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 17 Dec 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium
- EC Number:
- 279-899-9
- EC Name:
- (ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium
- Cas Number:
- 82089-64-3
- Molecular formula:
- C14H22O7Ti
- IUPAC Name:
- 13-ethoxy-8,10,15-trimethyl-1λ³,5λ³-dioxa-7λ³,11λ³,12,16-tetraoxa-6-titanaspiro[5.5⁶.5⁶]hexadeca-7,10-diene-6,6,6,6-tetrakis(ylium)-1,5,9,14-tetraide
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS Limited, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 163 - 185g (main study)
- Fasting period before study: overnight fast immediately before and approx. 3 -4 hours after dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages with woodflakes
- Diet: free access to food (2014C Teklad Global Rodent diet)
- Water: free access to main drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Doses:
- 300 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 2000 mg/kg: 1 animal (sighting study)
300 mg/kg: 1 animal (sighting study)
300 mg/kg: 5 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Morbidity and mortality checks twice daily, once daily at weekend and public holidays; weighing on days 0, 7 and 14 d or at death
- Necropsy of survivors performed: yes
- Clinical observations: 30 min, 1, 2, 4 h afer dosing, then daily up to 14 d
Results and discussion
- Preliminary study:
- Sighting study: In the absence of toxicity at a dose level of 300 mg/kg tested in one animal, an additional animal was treated with 2000 mg/kg. At this dose level, the signs of systemic toxicity noted were hunched posture, lethargy, noisy and labored respiration, pilo-erection and dehydration. The tested animal was killed for humane reasons, 1 day after dosing.
Due to mortality and signs of systemic toxicity in the "main test" a group of five animals was tested with 300 mg/kg.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose level - 2000 mg/kg (sighting study): the animal was killed 1 day after dosing, due to the occurrence of clinical signs of toxicity that were considered likely to exceed the severity limit.
Dose level - 300 mg/kg: no death - Clinical signs:
- other: Dose level - 2000 mg/kg (sighting study): Signs of systemic toxicity noted were hunched posture, lethargy, noisy and labored restiration, pilo-erection and dehydration Dose level - 300 mg/kg: No signs of systemic toxicity noted during the observation peri
- Gross pathology:
- Necropsy:
Dose level - 2000 mg/kg (sighting study): Gaseous stomach and test item present in the stomach
Dose level - 300 mg/kg: No abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (CLP - Category 4).
- Executive summary:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (CLP - Category 4).
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