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EC number: 212-480-0 | CAS number: 821-55-6
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- Combined repeat dose and reproductive / developmental toxicity 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 HPV Challenge Program
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Revised Robust Summaries for Ketone Bottoms ( KB4/KB3) CAS NO. 68990-20-5, Eastman Chemical Company
- Author:
- Eastman Chemical Company
- Year:
- 2 007
- Bibliographic source:
- HPV Challenge Program, Eastman Chemical Company, 17 April 2007, page no 1-238
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Combined repeat dose and reproductive / developmental toxicity test of 2-Nonanone in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nonan-2-one
- EC Number:
- 212-480-0
- EC Name:
- Nonan-2-one
- Cas Number:
- 821-55-6
- Molecular formula:
- C9H18O
- IUPAC Name:
- nonan-2-one
- Reference substance name:
- 2-Nonanone
- IUPAC Name:
- 2-Nonanone
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-Nonanone
- Molecular formula (if other than submission substance): C9H18O
- Molecular weight (if other than submission substance): 142.24g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): 99%.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Nonanone
- Molecular formula (if other than submission substance): C9H18O
- Molecular weight (if other than submission substance): 142.24g/mole
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): < 1%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- air
- Remarks:
- Filtered room
- Details on exposure:
- No data available.
- Details on mating procedure:
- No data available.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 50 days
- Frequency of treatment:
- 6 hours/day, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 80, 400, or 1000 ppm. Actual exposure concentrations 0, 78.6, 405.8 or 1022.6 ppm (0,7.86, 40.58 and 102.26 )
Basis:
actual ingested
- No. of animals per sex per dose:
- No data available.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available.
- Positive control:
- No data available.
Examinations
- Parental animals: Observations and examinations:
- Survival, Clinical sign, Body weight and food consumption were observed.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- Analysis of epididymal spermatozoan numbers and motility, and testicular spermatid head countswere determined.
- Litter observations:
- Live pups, Clinical signs and weight gain were observed.
- Postmortem examinations (parental animals):
- Organ weight, gross pathology and histopathology were observed.
- Postmortem examinations (offspring):
- Abnormalities were observed.
- Statistics:
- Homogeneity of data were evaluated by Bartlett's test (p, 0.01), analysis of variance (ANOVA, <0.05), and Dunnett's test (p, 0.05). When the variances of the means were not considered equal by Bartlett's test, the data were evaluated by Kruskal-Wallis H-test (p, 0.05) followed by Mann-Whitney U-test (p<0.05). The reproductive performance of dams and fertility and fecundity indices were evaluated in contingency tables, using Chi-square test (p,0.05). The total number of pups per litter (live and dead) and the total number of live pups per litter were evaluated by a linear regression model.
- Reproductive indices:
- Fertility and fecundity indices were observed.
- Offspring viability indices:
- The total number of pups per litter (live and dead) and the total number of live pups per litter were evaluated
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- 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
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not specified
Details on results (P0)
Mortality: No effect on survival of treated rats was observed as compared to control.
Clinical sign: Minimal reductions in activity level were observed in 40 and 100 mg/kg/day dose group.
No other abnormalities were observed in treated rats as compared to control.
Body weight: No effects were observed on body weight and weight gain of treated rats as compared to control.
Food consumption: In male rats, reduction in food consumption during days 0-7 hen treated with 100 mg/kg/day as compared to control.
Reproductive function: sperm measures: No change in mean sperm motility and mean epididymalspermatozoan and testicular spermatid counts were observed in treated male rats as compared to control.
Organ weights: No effect was observed on organ weight of treated rats as compared to control.
Gross pathology: No gross pathological changes were observed in treated rats as compared to control.
Histopathology: No histopathological changes in organs were observed in treated rats as compared to control.
Clinical sign: Minimal reductions in activity level were observed in 40 and 100 mg/kg/day dose group.
No other abnormalities were observed in treated rats as compared to control.
Body weight: No effects were observed on body weight and weight gain of treated rats as compared to control.
Food consumption: In male rats, reduction in food consumption during days 0-7 hen treated with 100 mg/kg/day as compared to control.
Reproductive function: sperm measures: No change in mean sperm motility and mean epididymalspermatozoan and testicular spermatid counts were observed in treated male rats as compared to control.
Organ weights: No effect was observed on organ weight of treated rats as compared to control.
Gross pathology: No gross pathological changes were observed in treated rats as compared to control.
Histopathology: No histopathological changes in organs were observed in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 7.86 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect were observed on Reproductive organ
- Remarks on result:
- other: No effect were observed on Reproductive organ
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- 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
- 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:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Clinical signs:No clinical sign were obsserved in pups as compare to control.
Body weight : No body weight gain were obsserved in pups as compare to control.
Gross pathology: No abnormalities were observed in pups as compared to control.
Body weight : No body weight gain were obsserved in pups as compare to control.
Gross pathology: No abnormalities were observed in pups as compared to control.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 102.26 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: No effect were observed on Reproductive organ
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- 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 (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 80 ppm (8 mg/kg/day) (actual dose 7.86 mg/kg/day)for P generation and 1000 ppm (100 mg/kg) (actual dose 102.26 mg/kg/day) for F1 generation when Sprague-Dawley male and female rats treated with 2-Nonanone by Inhalation.
- Executive summary:
In Combined repeated dose repro-devp. Screen test,Sprague-Dawleymale and female rats exposed to 2-Nonanoneby inhalation in the concentration of 0, 80, 400 and 1000 ppm. (0, 7.86, 40.58 and 102.26 mg/kg/day) Actual exposure concentrations is 0, 78.6, 405.8 and 1022.6 ppm (0,7.86, 40.58 and 102.26 mg/kg/day) 6 hours/day, 7 days/week for 50 days. No effect on survival,Body weight and weight gain were observed in treated rats as compared to control.Minimal reductions in activity level were observed in 40 and 100 mg/kg/day dose group andreduction in food consumption during days 0-7in 100 mg/kg/day dose groupwere observed as compared to control. In addition, no effects were observed on organ weight, gross pathology,Sperm parameterand histopathology of treated rats as compared to control. Similarly, no effects were observed on clinical sign, body weight gain and gross pathology of pups as compared to control. Therefore, NOAEL was considered to be80 ppm(8 mg/kg/day) (actual dose 7.86 mg/kg/day)for P generation and1000 ppm (100 mg/kg) (actual dose 102.26 mg/kg/day) for F1 generation whenSprague-Dawleymale and female rats treated with2-Nonanoneby inhalation6 hours/day, 7 days/week for 50 days.
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