Dodecyldimethylamine

Toxicity to reproduction

Administrative data

Endpoint:

toxicity to reproduction

Remarks:

other: reproduction/development

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

09/1994-02/1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to the OECD and it is GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyldimethylamine

EC Number:

203-943-8

EC Name:

Dodecyldimethylamine

Cas Number:

112-18-5

Molecular formula:

C14H31N

IUPAC Name:

dodecyldimethylamine

Details on test material:

- Physical state: clear liquid
- Storage: at room temperature
- Stability: stable for the duration of the study

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test species: Rat/Sprague-Dawley Crl
Source: Charles River Deutschlanf GmbH
Animals: Five groups of 10 male and 10 female rats each
Body weight: males: 313-340g and female: 216-242g
Age: 69-72 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil, DAB 10

Details on exposure:

Administration volume: 2 mL/kg b.w. /day
Dose-levels: Group 1: control (vehicle), Group 2: 50mg, Group 3: 150mg, Group: 300mg, Group:450mg (10 males / 10 females)

Details on mating procedure:

Mating was monogamous: 1 male and 1 female animal were placed together in one cage during the dark period.
Each morning the female were examined for the presence of sperm. If findings were negative, mating was repeated.

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

Males: 14 days prior to mating and during the 14-day mating period
Female: 14 days prior to mating and during the mating period, pregnancy and lactation period.

Frequency of treatment:

administered orally at a constant volume of 2 mL/kg b.w/dya on 7 days per week during the following periods:
males: two weeks orior to mating period and approx. 2 weeks post mating at least until the minimum total dosing period of 28 days had been completed.
females: throughout the study beginning two weeks prior to mating and continuing uo to, and including, day 3 post partum or the day before sacrifice.

Details on study schedule:

1 adaptation week and approx. 54 test days [14 days premating, (up to) 14 days mating, 22 days gestation. 4 days lactation]

Doses / concentrations

Remarks:

Doses / Concentrations:
50, 150, 300 and 450 mg/kg b.w./day
Basis:
nominal conc.

No. of animals per sex per dose:

control, low dose, low intermediate dose, high intermediate dose and hich dose [ 10 males / 10 females] for all doses

Control animals:

yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day (nominal)

Sex:

male/female

Remarks on result:

other: Generation not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Under the present test conditions the no-observed-effect level (NOEL) for both parent animals and their pups was 50 mg Dodecyldimethylamine / kg b.w./day, by gavage in a reproduction / devolopment toxicity screening test with rats.
150 mg/kg b.w./day were in the beginning lethal range for pregnant rats and in the toxic range for embryos/fetuses/pups.
Only one dam of the group treated with 300 mg/kg b.w./day delivered one female pup alive.