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EC number: 263-058-8 | CAS number: 61789-40-0
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- sub chronic toxicity study
- 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 from secondary source
Data source
Referenceopen allclose all
- Reference Type:
- other: secondary source
- Title:
- Reproductive toxicity study of test chemical
- Author:
- U. S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxic Substances (OPPTS)
- Year:
- 2 010
- Bibliographic source:
- U.S. Environmental Protection Agency Hazard Characterization Document. Published 2010.
- Reference Type:
- other: secondary source
- Title:
- Reproductive toxicity study of test chemical
- Author:
- Human and Environmental Risk Assessment
- Year:
- 2 005
- Bibliographic source:
- Human and Environmental Risk Assessment, 2005
- Reference Type:
- other: secondary source
- Title:
- Reproductive toxicity study of test chemical
- Author:
- OECD HPV Chemical Programme
- Year:
- 2 006
- Bibliographic source:
- SIDS Dossier, 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guideline 408
- Principles of method if other than guideline:
- Reproductive toxicity study of test material was performed on Sprague Dawley rats
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- EC Number:
- 263-058-8
- EC Name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- Cas Number:
- 61789-40-0
- Molecular formula:
- C19H38N2O3
- IUPAC Name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- Details on test material:
- IUPAC name:1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
Mol. formula:C19H38N2O3
Mol. wt.:342.52 g·mol−1
Smile:CCCCCCCCCCCC(=O)NCCC[N+](C)(C)CC([O-])=OCCCCCCCCCCCC(=O)NCCC[N+](C)(C)CC(=O)[O-]
InChI:[O-]C(=O)C[N+](CCCNC(=O)CCCCCCCCCCC)(C)C1S/C19H38N2O3/c1-4-5-6-7-8-9-10-11-12-14-18(22)20-15-13-16-21(2,3)17-19(23)24/h4-17H2,1-3H3,(H-,20,22,23,24)
Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl: CD(SD)BR)
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age: 5/6 weeks
- Weight at study initiation: male : 115-174 g, female : 97-150 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:Test material soluble in distilled water
DIET PREPARATION- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 250, 500, 1000 mg /kg-
Amount of vehicle (if gavage):10ml /kg bw
- Lot/batch no. (if required):
- Purity: - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 5 days/week
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 250, 500, 1000 mg /kg
- No. of animals per sex per dose:
- Total:800 mg/kg :
10 male and 10 female 250mg/kg:
10 male and 10 female: 500mg/kg
10 male and 10 female: 1000 mg/kg:
10 male and 10 female: 0 mg/kg - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: daily
BODY WEIGHT: Yes
Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes twice/week
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)
SACRIFICE :On day 92
GROSS NECROPSY: yes
HISTOPATHOLOGY / ORGAN WEIGHTS : yes - Postmortem examinations (offspring):
- No data available
- Statistics:
- Levene´s test (body weight, body weight gain, food consumption), ANOVA, Dunnett´s test (both for multiple group comparisons), Student-Newman-Keul (organ weight, chlinical chemistry, hematology data organ/body weight ratio with each one factor treatment)
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- There were no treatment-related mortalities
- 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:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment related effects on histopathology of testes, accessory sex organs, ovaries, uterus, prostate
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- Remarks on result:
- other: No effects on reproductive organ
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- 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:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to be 1000 mg/kg/day, as no effects on reproductive organ weight and histopathology, When male and female Sprague Dawley rats were treated with test chemical orally for 90 days.
- Executive summary:
- A 90 days subchronic toxicity study of test chemical was performed according to OECD TG 408 on male and female Sprague-Dawley rats. The test material was dissolved in distilled water at dose levels of 0, 250, 500 or 1000 mg/kg-day and administered via oral gavage route once a day for 5 days/week in dose volume 10ml/kg bw in Sprague-Dawley rats 10/sex/dose was used in the study. All the animals were observed for Clinical signs and mortality daily. Body weight and food consumption were noted twice a week. On day 92, all the animals were sacrificed and Gross pathology and Histopathology were performed. There were no treatment-related mortalities in any test group. No effects on Body weight and food consumption were noted. No effects on testes and ovaries weights were noted. No treatment related effects on histopathology of testes, accessory sex organs, ovaries, uterus and prostate were noted. Hence No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to be 1000 mg/kg/day, as no effects on reproductive organ weight and histopathology were observed, when male and female Sprague Dawley rats were treated with test chemical orally for 90 days.
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