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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
two-generation reproductive toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From NOV 1979 to NOV 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
SIDS Initial Assessment Report for SIAM 22
Author:
OECD
Year:
2006
Bibliographic source:
OECD Existing Chemicals Database
Report date:
2006

Materials and methods

Principles of method if other than guideline:
Two-generation study in rats
GLP compliance:
no
Remarks:
This study was conducted prior to the adoption of GLP compliance standards. However, it was conducted in accordance with the Japanese Ministry of Health and Welfare Guidelines, and was found to be acceptable by the laboratory´s Quality Assurance Unit.
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecyldimethylamine oxide
EC Number:
216-700-6
EC Name:
Dodecyldimethylamine oxide
Cas Number:
1643-20-5
Molecular formula:
C14H31NO
IUPAC Name:
dodecyl(dimethyl)amine oxide

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on mating procedure:
no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
approximately 4 months
Frequency of treatment:
daily
Details on study schedule:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 750, 1500, 3000 ppm for 6.5 weeks, doses were reduced to 0, 188, 375 and 750 ppm. 750 ppm corresponds to 40 mg /kg / day, 375 ppm corresponds to 20 mg/ kg / day, 188 ppm corresponds to 11 mg/ kg / day
Basis:
nominal in diet
No. of animals per sex per dose:
15 males, 30 females
Control animals:
yes, plain diet
Details on study design:
- Dose calculation according to SIDS.
Positive control:
no data

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: no data

BODY WEIGHT: Yes
- Time schedule for examinations:
F0:males: weekly, females: weekly until mating, then weighed an days 1, 3, 7, 14, 21 post coitum and on days 1, 4, 11, 18 and 25 post partum
F1: days 1, 4, 11, 18, 25 post partum

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: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes

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

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day: no
- Organs examined: adrenals, all tumors, brain, bone marrow, cecum, duodenum, epididymides, eye and optic nerve, heart, ileum, kidneys, liver, lungs, lymph nodes, mammary glands, esophagus, ovaries, pancreas, pituitary, prostate, seminal vesicles, spleen, stomach, testes, thymus, thyroid, urinary bladder and uterus
Oestrous cyclicity (parental animals):
no data
Sperm parameters (parental animals):
no data
Statistics:
Multiple t-test; Mann-Whitney U-test; x2-test; or Fisher´s Exact Probability test.
Reproductive indices:
no data
Offspring viability indices:
Details for first generation (F1) and second generation (F2)given.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
slight reductions in weight gain of both parents and offspring, but was without adverse effect on their mating performance and fertility
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
slight reductions in weight gain of both parents and offspring, but was without adverse effect on their mating performance and fertility
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Other effects:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: slight reduction in weight gain of both parents. Reductions in weight gain did not exceed 10%. The general condition of the animals throughout the study was unaffected by treatment.

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
mortality observed, treatment-related
Description (incidence and severity):
There was a slight reduction in the number of F2 offspring born at the 750 ppm level.
Body weight and weight changes:
no effects observed
Sexual maturation:
no effects observed
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Mating performance, fertility, and conception rate were not affected by treatment in either generation. Gestation and parturition proceeded normally.

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOAEL
Generation:
F2
Effect level:
> 40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test the NOAEL for the parent generation was established as >40 mg/kg bw/day. NOAEL values for F1 and F2 offsprings were >40 mg/kg bw/day as well. Slight reduction in weight gain of both parents was observed. Reductions in weight gain did not exceed 10%. The general condition of the animals throughout the study was unaffected by the treatment. Mating performance, fertility, and conception rate were not affected by treatment in either generation. Gestation and parturition proceeded normally. There was a slight reduction in the number of F2 offsprings born at the 750 ppm level, however there were no adverse effects of treatment on litter size at birth, live birth index and birth weight in either generation. Therefore, this was not considered an adverse effect.
Executive summary:

15 Male and 30 female Charles River CD rats per dose group were exposed to feed containing 0, 750, 1500, 3000 ppm test substance for 6.5 weeks, doses then were reduced to 0, 188, 375 and 750 ppm. This corresonds to: 0, 11, 20 and 40 mg/kg / day ad libitum for 101 days before mating, throughout mating, gestation and lactation.

Slight reduction in weight gain of both parents was observed. Reductions in weight gain did not exceed 10%. The general condition of the animals throughout the study was unaffected by the treatment. Mating performance, fertility, and conception rate were not affected by treatment in either generation. Gestation and parturition proceeded normally. There was a slight reduction in the number of F2 offsprings born at the 750 ppm level, however there were no adverse effects of treatment on litter size at birth, live birth index and birth weight in either generation. Therefore, this was not considered an adverse effect.

Under the conditions of the test the NOAEL for the parent generation was established as >40 mg/kg bw/day. NOAEL values for F1 and F2 offsprings were >40 mg/kg bw/day as well.