Registration Dossier
Registration Dossier
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EC number: 412-000-1 | CAS number: 125051-32-3 CGI 784
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other: inquiry result from ECHA
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive, B.7
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(η5-cyclopentadienyl)-bis(2,6-difluoro-3-[pyrrol-1-yl]-phenyl)titanium
- EC Number:
- 412-000-1
- EC Name:
- Bis(η5-cyclopentadienyl)-bis(2,6-difluoro-3-[pyrrol-1-yl]-phenyl)titanium
- Cas Number:
- 125051-32-3
- Molecular formula:
- C30H22F4N2Ti
- IUPAC Name:
- titanium(4+) bis(2,6-difluoro-3-(1H-pyrrol-1-yl)benzen-1-ide) bis(cyclopenta-2,4-dien-1-ide)
Constituent 1
Test animals
- Species:
- other: ALBINO RAT/Tif: RAlf (SPF) HYBRIDIS OF RII/1×RII/2
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on oral exposure:
- Method of administration:
ADMIXED IN FOOD - Duration of treatment / exposure:
- Test duration: 28 days
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 150 mg/kg bw/day
Male: 10 animals at 650 mg/kg bw/day
Male: 10 animals at 3000 mg/kg bw/day
Male: 10 animals at 12000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 150 mg/kg bw/day
Female: 10 animals at 650 mg/kg bw/day
Female: 10 animals at 3000 mg/kg bw/day
Female: 10 animals at 12000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
THE MOST FREQUENT CLINICAL SIGNS OBSERVED DURING THE STUDY WERE HUNCHED POSTURE, PILOERECTION AND PALE EYES IN MALES OF GROUPS 3 TO 5 (650, 3000 AND 12000 PPM) AND IN FEMALES OF GROUP 5 (12000 PPM). IN ADDITION CONVULSION, LETHA RGY, PROSTRATION AND/OR IRREGULAR/LABOURED RESPIRATION WERE OBSERVED IN A FEW MALES OF GROUPS 4 AND 5 (3000 AND 12000 PPM) PRECEDING DEATH.
NO RECOVERY WAS OBSERVED DURING THE WITHDRAWAL PERIOD.
7 MALES OF GROUP 5 (12000 PPM), 9 MALES OF GROUP 4 (3000 PPM) AND 4 MALES OF GROUP 3 (650 PPM) WERE EITHER FOUND DEAD OR WERE SACRIFICED IN MORIBUND CONDITIONS BETWEEN DAY 6 AND 44. THE MEAN BODYWEIGHTS AT THE END OF THE TREA TMENT PERIOD WERE REDUCED IN ALL TREATED MALE GROUPS AND IN FEMALES OF GROUP 5 (12000 PPM).
AT THE END OF RECOVERY PERIOD, THE MEAN BODYWEIGHT OF GROUP 3 MALES WAS STILL DEPRESSED.
Laboratory findings:
A MARKED ANEMIA WITH METHEMGL0BINEMIA AND NEUTROPHILIA OCCURRED AT 650 TO 12000 PPM IN MALES AND THROMBOPENIA WAS NOTED IN ALL TREA TED MALE AND FEMALE GROUPS.
Effects in organs:
BLOOD CHEMISTRY INV ESTIGATION (INCREA SED LIVER ENZYMES, CHOLESTEROL, TRIGLYCERIDES, BILIRUBIN, CREATININ AND UREA, DECREASED PLASMA PROTEINS. EFFECTS WERE SEEN ALSO IN MALES AT 150 PPM), ORGAN WEIGHT ANALYSIS (INCREASED KIDNEY AND OECREASED LIVER AND TESTIS RELATIVE WEIGHT AT >= 650 PPM) AND HISTOPA THOLOGY (LIVER NECROSIS, INTRAHEPA TIC BILIARY DUCTHY PERPLASIA, HYPERTROPHY OF HEPA TOCYIES, DILATATION OF RENAL TUBULES, REDUCED SPERMA TOGENESIS, LEYDIG ALL ATROPHY AT >= 650 PPM) IDENTIFIED LIVER, KIDNEY AND TESTIS AS TARGET ORGANS. MALES WERE MORE SEVERELY EFFECTED THAN FEMALES. THE NUMEROUS METABOLIC ALTERATIONS AND THE EFFECTS ON BLOOD CLOTTING WERE CONSIDERED CONSEQUENCES OF HEPATOTOXICITY.
WITHIN THE RECOVERY PERIOD THE EFFECTS ON HEMA TOLOGICAL AND BLOOD CHEMISTRY VALUES SHOWEO SOME DEGREE OF REVERSIBILITY AND NO HISTOPATHOLOGICAL CHANGES WERE DETECTED AFTER RECOVERY IN MALES AT 150 PPM AND IN FEMALES AT TO 150 PPM.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 10.8 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 10.8 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Xn - harmful
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