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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
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 TSCA

Data source

Reference
Reference Type:
secondary source
Title:
Reproductive toxicity of CAS no 2437-25-4
Author:
TSCA
Year:
2006
Bibliographic source:
US Environmental Protection Agency, TSCA, June 12,2006,

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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:
Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening in rats
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecanenitrile
EC Number:
219-440-1
EC Name:
Dodecanenitrile
Cas Number:
2437-25-4
Molecular formula:
C12H23N
IUPAC Name:
dodecanenitrile
Details on test material:
SMILES:CCCCCCCCCCCC#N
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dodecanenitrile
- Molecular formula (if other than submission substance): C12H23N
- Molecular weight (if other than submission substance): 181.321 g/mole
- Substance type: Organic

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
not specified
Details on mating procedure:
not specified
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
47 days
Frequency of treatment:
Daily
Details on study schedule:
not specified
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
50 mg/kg bw/day
Dose / conc.:
250 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
not specified
Control animals:
yes
Details on study design:
not specified
Positive control:
not specified

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: yes

BODY WEIGHT: Yes
Time schedule for examinations: No data

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
Oestrous cyclicity (parental animals):
not specified
Sperm parameters (parental animals):
not specified
Litter observations:
Survival and body weight were examined.
Postmortem examinations (parental animals):
Organ weight and Gross pathology were examined.
Postmortem examinations (offspring):
not specified
Statistics:
not specified
Reproductive indices:
viability index were examined.
Offspring viability indices:
yes

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
mortality observed, treatment-related
Description (incidence):
At 1000 mg/kg bw, After giving birth 4 dams died spontaneously on day 1 post partum.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
When treated wtih 1000 mg/kg bw, mean body weight gain were decreased in male rat and during the lactation period in female rat.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
When treated wtih 1000 mg/kg bw, mean food consumption gain were decreased in male rat and during the lactation period in female rat.
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:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
not specified
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:
effects observed, treatment-related
Description (incidence and severity):
When treated with 50 mg/kg bw, one female was not pregnant.

When treated with 100 mg/kg bw, no mating was observed for one female.

When treated with 1000 mg/kg bw, two females were not pregnant and one female was killed in extremis on day 3 of the gestation.
After giving birth 4 dams died spontaneously on day 1 post partum and two dams were killed in extremis on days 1 and 4 post partum, respectively.

Statistically significant decrease in birth and viability index were observed in treated rats as compared to control.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality
body weight and weight gain
food consumption and compound intake
organ weights and organ / body weight ratios
gross pathology
reproductive performance
other: No effect observed

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:
mortality observed, treatment-related
Description (incidence and severity):
When treated wtih 1000 mg/kg bw, Statistically significant decrease in viability index were observed in treated rats as compared to control.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
When treated wtih 1000 mg/kg bw, pup body weight were slightly reduced on day 1 post partum but distinctly reduced on day 4 post partum; however the
results were based only on the data of one litter.

When treated with 50 and 250 mg/kg bw, Body weights of male and female pups were slightly decrease on day 1 post partum and similar to the control on day 4 post partum. Since there were more pups per litter in these groups this is considered to be incidental.
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:
NOAEL
Generation:
F1
Effect level:
250 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
body weight and weight gain
other: No effect observed

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 adverse effect level (NOAEL) was considered to be 250 mg/kg for P and F1 generation when male and female rats were treated with Dodecanenitrile orally by gavage for 47 days.
Executive summary:

In Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening test, male and female rats were treated with Dodecanenitrile in the concentration of 0, 50, 250 and 1000 mg/kg bw orally by gavage for 47 days (mating period, gestation and early lactation phase). At 1000 mg/kg bw, After giving birth 4 dams died spontaneously on day 1 post partum. Mean body weight gain and food consumption were decreased in male rat and during the lactation period in female rat at 1000 mg/kg bw. One female was not pregnant at 50 mg/kg bw, no mating was observed for one female at 100 mg/kg bw and two females were not pregnant and one female was killed in extremis on day 3 of the gestation at 1000 mg/kg bw. After giving birth 4 dams died spontaneously on day 1 post partum and two dams were killed in extremis on days 1 and 4 post partum, respectively. Statistically significant decrease in birth and viability index was observed in 1000 mg/kg bw treated rats as compared to control. Similarly, statistically significant increase in liver weights was observed in male rats. For female, due to the fact that there was only one female, no conclusion could be reached concerning liver weights at 1000 mg/kg bw. Increase in liver weights were observed in 50 and 250 mg/kg bw treated female rats, but not statistically significantly and not dose dependently. Unexpected black-brown contents in stomach, intestine and/or caecum were observed in all groups, which were considered not to be test item-related. In addition, statistically significant decrease in viability index were observed in treated rats at 1000 mg/kg bw as compared to control. At 1000 mg/kg bw, pup body weight were slightly reduced on day 1 post partum but distinctly reduced on day 4 post partum; however the results were based only on the data of one litter. At 50 and 250 mg/kg bw, Body weights of male and female pups were slightly decrease on day 1 post partum and similar to the control on day 4 post partum. Since there were more pups per litter in these groups this is considered to be incidental. Therefore, No adverse effect level (NOAEL) was considered to be 250 mg/kg for P and F1 generation when male and female rats were treated with Dodecanenitrile orally by gavage for 47 days.