Registration Dossier
Registration Dossier
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EC number: 219-535-8 | CAS number: 2457-01-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June - July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued 2012-07-18
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Barium bis(2-ethylhexanoate)
- EC Number:
- 219-535-8
- EC Name:
- Barium bis(2-ethylhexanoate)
- Cas Number:
- 2457-01-4
- Molecular formula:
- C8H16O2.1/2Ba
- IUPAC Name:
- barium bis(2-ethylhexanoate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2.018g/10mL (high dose), 0.3005 and 0.3004g/10mL (low dose)
- MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw - Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- Dose group 2000mg/kg bw: 3 animals
Dose group 300mg/kg bw: 6 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: behavioural or toxic effects on the major physiological functions - Statistics:
- not performed
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 3/3 in 2000mg/kg bw dose group, 1h post dose
1/6 in 300mg/kg bw dose group, 23h 15min post dose - Clinical signs:
- other: 2000mg/kg bw dose group: absence of spontaneous activity (3/3), Preyer's reflex (3/3), righting reflex (3/3), muscle tone (3/3), bradypnoea (3/3), salvation (1/3) 300mg/kg bw dose group: decrease of spontaneous activity (2/5), salvation (2/5), piloerectio
- Gross pathology:
- 2000mg/kg bw dose group: white colouration of the forestomach (3/3), red spots on the corpus (3/3)
300mg/kg bw dose group: rigor mortis before necropsy, marked lysis prevented macroscopic examination, surviving animals did not reveal treatment related changes
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item barium bis(2-ethylhexanoate) is higher than 300mg/kg bw and lower than 2000mg/kg bw by oral route in the rat.
In accordance with directive 67/548/EEC, the test item barium bis(2-ethylhexanoate) has to be classified with Xn, R22 (Harmful if swallowed).
In accordance with regulation (EC) 1272/2008 the test item barium bis(2-ethylhexanoate) has to be classified in category 4, H302 (Harmful if swallowed) and the signal word "Warning" be assigned.
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