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Registration Dossier
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EC number: 237-358-4 | CAS number: 13762-14-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jun. 23 - Nov. 15, 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- but no impact on results
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cobalt molybdate
- EC Number:
- 237-358-4
- EC Name:
- Cobalt molybdate
- Cas Number:
- 13762-14-6
- Molecular formula:
- CoMoO4
- IUPAC Name:
- λ²-cobalt(2+) dioxomolybdenumbis(olate)
- Details on test material:
- - Name of test material (as cited in study report): Cobalt molybdenum oxide
- Physical state: light green powder
- Analytical purity: 99%
- Lot/batch No.: EH 110005/1
- Expiration date of the lot/batch: Jun. 2013
- Storage condition of test material: stored in a closed vessel at room temperature (20 ± 5 °C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 0.5 % sodium carboxymethyl cellulose
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 33 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 in control and 100 mg/kg bw/d groups
5 in 10 and 33 mg/ kg bw/d groups - Control animals:
- yes, concurrent vehicle
- Details on study design:
- 14-day recovery period for some animals (s. below)
Examinations
- Observations and examinations performed and frequency:
- clinical signs
body weight (twice per week during treatment, once per week during recovery)
feed intake (once per week)
urine, vaginal smear (at end of treatment and recovery) - Sacrifice and pathology:
- Sacrifice:
- All animals of 10 and 33 mg/kg bw/d groups after end of treatment.
- Solvent control and 100 mg/kg bw/d groups: 5 males and 5 females of each group after end of treatment and end of recovery, i.e. all animals were sacrificed.
Pathology:
- solvent controls: haematology, clinical biochemistry, organ weight, gross pathology, histopathology
- 10, 33 mg/kg bw/d groups: histopathology (spleen only)
- 100 mg/kg bw/d group: haematology, clinical biochemistry, urine, organ weight, gross pathology, histopathology
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Males of the 100 mg/kg bw/d group showed lower body weights compared to control from day 10 of treatment until the end of recovery (cf. attached table below).
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males of 10 mg/kg bw/d group showed only decreased food intake on day 3, and females of the same dose level increased intake on day 17. Also, males of 100 mg/kg bw/d group showed decreased food intake only on day 24, and females of the same dose level increased intake on days 10 and 17. No toxicological significance was attributed to these variations, since they were not time- or dose-dependent.
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- checked were: RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RET, RET%, APTT and PT
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- checked were: TP, ALB, GLB, A/G, ALT, AST, ALP, GGT, CK, LDH, UREA, CREA, GLU, TBIL, CHOL, TG, Ca, PHOS, K+, Na+ and Cl-
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- examined were: thyroid, parathyroid, liver, spleen, kidney, adrenal gland, testicle, epididymides, prostate gland, seminal vesicle, ovary, uterus, thymus gland, heart and brain
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- examined were: thyroid, parathyroid, liver, spleen, kidney, adrenal gland, testicle, epididymides, prostate gland, seminal vesicle, ovary, uterus, thymus gland, heart, brain, lungs, stomach, intestine and lymph nodes
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- examined were (100 mg/kg bw/d group): thyroid, parathyroid, liver, spleen, kidney, adrenal gland, testicle, epididymides, prostate gland, seminal vesicle, ovary, uterus, thymus gland, heart, brain, lungs, stomach, intestine and lymph nodes
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- clinical biochemistry
- clinical signs
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- urinalysis
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Excect for a non-reversible weight lost in male rats of the highest dose group (100 mg/kg bw/d), no toxicological effects were observed. Therefore the NOAEL was >= 100 mg/kg bw/d.
- Executive summary:
The study examined the oral toxicity potential of cobalt molybdenum oxide after 28-day oral exposure and 14-day recovery in rats.
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