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Toxicological information

Toxicity to reproduction

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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:
2010
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:
2005
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:
2006
Bibliographic source:
SIDS Dossier, 2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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

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 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.