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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From MAY 1980 to OCT 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Principles of method if other than guideline:
Test for developmental toxicity.
GLP compliance:
no
Remarks:
This study was conducted prior to 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:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Animals were artificially inseminated using pooled semen from New Zealand White bucks.
Duration of treatment / exposure:
days 6-18 (inclusive) of gestation
Frequency of treatment:
daily
Duration of test:
approximately 5 months
No. of animals per sex per dose:
14 female animals per dose group
Control animals:
yes, concurrent vehicle
Details on study design:
no data

Examinations

Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: daily, reported on days 0, 6, 8, 10, 12, 14, 16, 18, 23, 28.

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

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

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: no data
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other:
Fetal examinations:
- External examinations: Yes
- Soft tissue examinations: No
- Skeletal examinations: Yes: (all)
- Head examinations: No
Statistics:
Multiple ´t´-test, ´t´-test, Mann-Whitney U-test, Chi-squared test and Fisher´s Exact Probability test (Armitage modification).
Indices:
no data
Historical control data:
no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes. Remark: details see below

Details on maternal toxic effects:
Maternal condition was generally unaffected by treatment with the test material; however, maternal bodyweight gain was depressed in all treated groups, although at 40 mg/kg/day terminal bodyweights similar to those of controls were achieved. Three females receiving 80 mg/kg/day and three females receiving 160 mg/kg/day died or were killed in extremis, but no direct involvement of the test substance was apparent. Food intake, when compared with pre-treatment values, was reduced during the second half of the treatment period in groups receiving 40 and 80 mg/kg/day, and from the commencement of treatment in animals receiving 160 mg/kg/day. Water intake was also decreased in all treated groups. Reductions in body weight gain, food intake and water intake did not exceed 10%.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
> 160 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
Litter response was unaffected by any treatment with the test material. No adverse effects upon litter responses and development were recorded. No teratogenic responses were observed.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
> 160 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test, the maternal animals were generally unaffected by treatment with the test material; however, maternal bodyweight gain was depressed in all treated groups, although at 40 mg/kg/day terminal bodyweights similar to those of controls were achieved. Food intake, when compared with pre-treatment values, was reduced during the second half of the treatment period in groups receiving 40 and 80 mg/kg/day, and from the commencement of treatment in animals receiving 160 mg/kg/day. Water intake was also decreased in all treated groups. Reductions in body weight gain, food intake and water intake did not exceed 10%. The NOAEL for maternal toxicity was established as > 160 mg/kg bw/day
Litter response was unaffected by any treatment with the test material. No adverse effects upon litter responses and development were recorded. No teratogenic responses were observed. The NOAEL for teratogenicity was established as > 160 mg/kg bw/day
Executive summary:

14 New Zealand white rabbits per dose group were exposed to 0, 40, 80 or 160 mg test substance/kg bw/day during days 6 -18 og gestation.

Under the conditions of the test, the maternal animals were generally unaffected by treatment with the test material; however, maternal bodyweight gain was depressed in all treated groups, although at 40 mg/kg/day terminal bodyweights similar to those of controls were achieved. Food intake, when compared with pre-treatment values, was reduced during the second half of the treatment period in groups receiving 40 and 80 mg/kg/day, and from the commencement of treatment in animals receiving 160 mg/kg/day. Water intake was also decreased in all treated groups. Reductions in body weight gain, food intake and water intake did not exceed 10%.

Litter response was unaffected by any treatment with the test material. No adverse effects upon litter responses and development were recorded. No teratogenic responses were observed.

The NOAEL for maternal toxicity was established to be > 160 mg/kg bw/day.

The NOAEL for teratogenicity is > 160 mg/kg bw/day.