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Registration Dossier
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EC number: 947-402-0 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in Wistar Rats with test chemical
- Author:
- USEPA
- Year:
- 2 012
- Bibliographic source:
- BASF Corporation, OTS0601595 United States Environmental Protection Agency, 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- In order to evaluate the toxicity of test chemical Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was conducted in male and female Wistar Rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 770661-17-1
- Molecular formula:
- C35H46N5O4
- Reference substance name:
- Reference substance 001
- Cas Number:
- 16887-00-6
- Molecular formula:
- Cl
- Test material form:
- liquid
- Details on test material:
- - Name of test material : Reaction mass of 1-Propanaminium, 3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propen-1-yl]oxy]-N-[2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propen-1-yl]oxy]ethyl]-N,N-dimethyl- & chloride- Molecular formula : C35H46ClN5O4- Molecular weight : 636.232 g/mol- Smiles notation : C(CCOC(\C(=C\c1ccc(cc1)N(CC)CC)C#N)=O)[N+](C)(C)CCOC(\C(=C\c1ccc(cc1)N(CC)CC)C#N)=O.[ClH-]- InChl : 1S/C35H46N5O4.ClH/c1-7-38(8-2)32-16-12-28(13-17-32)24-30(26-36)34(41)43-22-11-20-40(5,6)21-23-44-35(42)31(27-37)25-29-14-18-33(19-15-29)39(9-3)10-4;/h12-19,24-25H,7-11,20-23H2,1-6H3;1H/q+1;/p-1/b30-24+,31-25+;- Substance type: Organic- Physical state: Liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material : Reaction mass of 1-Propanaminium, 3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propen-1-yl]oxy]-N-[2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propen-1-yl]oxy]ethyl]-N,N-dimethyl- & chloride- Molecular formula : C35H46ClN5O4- Molecular weight : 636.232 g/mol- Smiles notation : C(CCOC(\C(=C\c1ccc(cc1)N(CC)CC)C#N)=O)[N+](C)(C)CCOC(\C(=C\c1ccc(cc1)N(CC)CC)C#N)=O.[ClH-]- InChl : 1S/C35H46N5O4.ClH/c1-7-38(8-2)32-16-12-28(13-17-32)24-30(26-36)34(41)43-22-11-20-40(5,6)21-23-44-35(42)31(27-37)25-29-14-18-33(19-15-29)39(9-3)10-4;/h12-19,24-25H,7-11,20-23H2,1-6H3;1H/q+1;/p-1/b30-24+,31-25+;- Substance type: Organic- Physical state: Liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days for male 55 days for female
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0,100, 300 and 1000 mg/kg bw/day
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes DETAILED CLINICAL OBSERVATIONS: Yes BODY WEIGHT: Not specified FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified - Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified FOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified OPHTHALMOSCOPIC EXAMINATION: Not specified HAEMATOLOGY: Not specified CLINICAL CHEMISTRY: Yes ,Parameters such as creatinine, urea and potassium level were observedURINALYSIS: Not specified NEUROBEHAVIOURAL EXAMINATION: Not specified
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, the male animals were necropsied after 28 days of administration of test chemical.HISTOPATHOLOGY: Yes , Animals were observed microscopically.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No significant effect was observed at dose level of 0,100, 300 and 1000 mg/kg bw/day in treated group compare to control.
- Mortality:
- no mortality observed
- Description (incidence):
- No significant effect was observed at dose level of 0,100, 300 and 1000 mg/kg bw/day in treated group compare to control.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase in creatinine levels were observed at the dose level of 1000 mg/kg bw/day in treated group compare to control.Even Increased urea and potassium levels were observed at the dose level of 1000 mg/kg bw/day in treated female group compare to control.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Minimally increased occurrence of single cell necrosis or apoptosis in the liver of six males and three females were observed at the dose level of 1000 mg/kg bw/day in treated group compare to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 300 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect was observed at this dose.
Target system / organ toxicity
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 300 mg/kg/day in Wistar male and female rats, when they were treated withReaction mass of 1-Propanaminium, 3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propen-1-yl]oxy]-N-[2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxo-2-propen-1-yl]oxy]ethyl]-N,N-dimethyl- & chloride by oral gavage for subchronic study.
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was conducted for test chemical by OECD guideline 422.The test chemical was exposed to Wistar male and female rat were in the concentration of 0, 100, 300 and 1000 mg/kg bw/day by oral gavage for 56 days . The animals were observed for mortality, clinical sign, clinical chemistry, gross pathology and histopathology. Increased creatinine levels were observed in male and female rats while increased urea and potassium levels in female rats at dose level of 1000 mg/kg/day. In addition, minimal increased occurrence of single cell necrosis or apoptosis in the liver of six males and three females at 1000 mg/kg/day were observed. No significant adverse effect at 100 and 300 mg/kg bw was observed. Therefore NOAEL was considered to be 300 mg/kg/day in Wistar male and female rats, when they were treated with test chemical by oral gavage for subchronic study.
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