Registration Dossier
Registration Dossier
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EC number: 242-538-0 | CAS number: 18727-04-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Feb 2012 - 07 Mar 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Secrétariat général du GIPC - DGCIS, Services de l'industrie, bureau de la chimie, Paris, France
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Tricobalt dicitrate
- EC Number:
- 212-751-3
- EC Name:
- Tricobalt dicitrate
- Cas Number:
- 866-81-9
- IUPAC Name:
- tricobalt dicitrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Cobalt Citrate
- Date received: 26 January 2012
- CAS No.: 866-81-9
- Physical state: solid powder
- Colour: purple
- Analytical purity: 99%
- Storage: room temperature
- Batch No.: 10142709
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Additional information on strain: SPF Caw
- Source: Elevage Janvier (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Fasting period before study: yes (food was removed on day 0 and then redistributed 4 hours post-application)
- Weight at study initiation: 196 - 212 g
- Housing: 3/cage in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid
- Diet: pelleted M20 rat/mouse maintenance diet (Extralabo from Pietrement); ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: step 1 and 2: 200 mg/mL; step 3 and 4: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw (step 1 and 2)
300 mg/kg bw (step 3 and 4) - No. of animals per sex per dose:
- 3 per step (females)
- Control animals:
- other: no concurrent control; vehicle control tested approx. 2 months before
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, 2, 7, and 14
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The LD 50 cut-off value is considered to be 500 mg/kg bw according to the OECD guideline No. 423.
- Mortality:
- - 2000 mg/kg bw: 6/6 animals died
(step 1: 1/3 on day 3, 2/3 on day 5; step 2: 2/3 on day 3, 1/3 on day 4)
- 300 mg/kg bw: 0/6 animals died - Clinical signs:
- other: - 2000 mg/kg bw: decrease in spontaneous activity (6/6), decrease in muscle tone (1/6), decrease in righting reflex (1/6), and piloerection (4/6) (all signs from 48 hours post-treatment) - 300 mg/kg bw: No clinical signs related to the administeration of
- Gross pathology:
- - 2000 mg/kg bw: Due to marked signs of autolysis, the macroscopical examinations were not possible in 5/6 animals. Examination of one dead animal revealed an important thinning of the forestomach and a thinning of the corpus with black spots.
- 300 mg/kg bw: No treatment-related findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Acute Oral 4, H302
DSD: Xn, R22
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