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Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: inhalation
Remarks:
combined repeated dose and reproduction / developmental screening
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

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 Kodak Co.
Year:
2007
Bibliographic source:
USEPA HPV dossier,Eastman Chemical Company, page 221, 2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD:TG- 421
Principles of method if other than guideline:
Combined repeated dose repro-devp. Screen of 2-Nonanone in Sprague-Dawley rats
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Nonan-2-one
EC Number:
212-480-0
EC Name:
Nonan-2-one
Cas Number:
821-55-6
IUPAC Name:
nonan-2-one
Constituent 2
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%.

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:
not specified
Vehicle:
air
Remarks on MMAD:
MMAD / GSD: No data available
Details on inhalation exposure:
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, 78.6, 405.8 or 1022.6 ppm
Basis:
other: Actual exposure concentrations
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

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data available

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION – Yes
AND COMPOUND INTAKE (if feeding study):

FOOD EFFICIENCY:
No data available

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available

OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: Analysis of epididymal spermatozoan numbers and motility, and testicular spermatid head counts were determined.

CLINICAL CHEMISTRY: No data available

URINALYSIS: No data available

NEUROBEHAVIOURAL EXAMINATION: No data available
OTHER: Organ weight: The testes and epididymis were also weighed.
Sacrifice and pathology:
GROSS PATHOLOGY: Yes HISTOPATHOLOGY: Yes, The ovaries, vagina, uterus, Fallopian tubes, and testes, epididymis, and male accessory sex organs were examined histologically.
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.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
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:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
Mortality-No mortality was observed in any group .

Clinical sign- Except for minimal reductions in activity level observed in the 400 and 1000 ppm groups during each exposure, no other test substance-related clinical abnormalities were noted.

Body weight and weight gain Body weight: There were no test substance-related changes in mean terminal body weight, mean body weight, body weight gain in treated group when compared to control.

Food consumption: For the 1000 ppm male group, there was a reduction in food consumption during days 0-7.

Food efficiency: No data available

Water consumption and compound intake: No data available

Opthalmoscopic examination No data available

Haematology No significant change were observed in Mean sperm motility and mean epididymal spermatozoan and testicular spermatid counts in treated group when compared to control group.

Clinical chemistry: No data available

Urinanalysis: No data available

Neurobehaviour: No data available

Organ weights No test substance-related significant change were observed in organ weight in treated group when compared to control group.

Gross pathology: No test substance-related significant change were observed in organ weight in treated group when compared to control group.

Histopathology: No exposure-related changes were observed during histological examination of the reproductive organs of any of the test substance-exposed parental male and female rats.

Details on results@ Embryotic / teratogenic effect and details- There were no treatment-related changes in pup clinical signs, weight gain, or abnormalities compared to controls at any of the test concentrations.

Effect levels

Dose descriptor:
NOAEL
Effect level:
80 mg/L air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No test substance-related clinical sign , body weight,food consumption , gross and histopathological abnormalities

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL were found to be 80 mg/L for 2-Nonanone by inhalation route.
Executive summary:

In Combined repeated dose repro-devp. Screen study for 2-Nonanone by inhalation route for 6 hours/ day for a week was observed in male and female Sprague-Dawley rats .They were exposed in concentration of 0, 80, 400, or 1000 ppm.Males were exposed for 50 days; females were exposed for 34-47 days (through day 19 of gestation).The ovaries, vagina, uterus, Fallopian tubes, and testes, epididymis, and male accessory sex organs were examined histologically. The testes and epididymis were also weighed. The study design also included an analysis of epididymal spermatozoan numbers and motility, and testicular spermatid head counts.All adult animals survived to study termination and there were no test substance-related changes in mean terminal body weight. For the 1000 ppm male group, there was a reduction in food consumption during days 0-7. Otherwise, there were no other differences in mean body weight, body weight gain, food consumption or food utilization among the groups throughout the study. Except for minimal reductions in activity level observed in the 400 and 1000 ppm groups during each exposure, no other test substance-related clinical abnormalities were noted. Mean sperm motility and mean epididymal spermatozoan and testicular spermatid counts were comparable among the groups. No test substance-related gross pathology was observed for adult animals from any group. No exposure-related changes were observed during histological examination of the reproductive organs of any of the test substance-exposed animals.There were no treatment-related changes in pup clinical signs, weight gain, or abnormalities compared to controls at any of the test concentrations.Therefore NOAEL were found to be 80 mg/L for2-Nonanone by inhalation route.