Dimethylaminopropylmethacrylamide, dodecyl bromide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29/03/05 - 27/04/05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide

Cas Number:

129684-50-0

Molecular formula:

C21H43N2O.Br

IUPAC Name:

N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide

Test material form:

liquid: viscous

Test animals

Species:

other: Albino rat

Strain:

other: Crl:CD®(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

Body Weight Range: Approximately 170 to 300 grams at initiation of dosing, ± 20% of the mean of previously tested animals.

Approximate Age: Eight to 12 weeks old at initiation of dosing.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was dosed undiluted based on its specific gravity. The dose volume was determined by dividing the dose levels of 360, 630, 1120 and 2000 mg/kg (represented as g/kg for the purpose of dose calculations) by the specific gravity (1.0463 g/mL, as determined by WIL Research Laboratories, LLC pharmacy personnel). Individual doses were calculated based on fasted body weights taken just prior to dosing and the dose volumes of 0.34, 0.60, 1.1 and 1.9 mL/kg for the 360, 630, 1120 and 2000 mg/kg groups, respectively.

Doses:

360, 630, 1120 and 2000 mg/kg

No. of animals per sex per dose:

Group 1 consisted of two animals, Group 2 consisted of three animals and Groups 3 and 4 consisted of one animal each.

Control animals:

no

Details on study design:

The acute oral toxicity of Cationic Surfactant DP/CR 2287 was evaluated in this single-dose study in rats. The test article was administered once orally via gavage to four groups of fasted female albino rats at dose levels of 360, 630, 1120 and 2000 mg/kg. Group 1 consisted of two animals, Group 2 consisted of three animals and Groups 3 and 4 consisted of one animal each. The study was conducted using the EPA-provided software package AOT425StatPgm, Version 1.0 (Westat) (Appendix A) using a limit test level of 5.0 g/kg, assumed LD50 of 2000 mg/kg and assumed sigma of 0.25 mg/kg. Dosing was discontinued when AOT425StatPgm indicated that the stopping criteria had been met. Mortality, clinical observations and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy.

Statistics:

At the termination of the project, all data will be collected and the acute oral median lethal dose (LD50) will be determined using the EPA-provided statistical program AOT425StatPGM (Westat).

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

360 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

414 mg/kg bw

Based on:

test mat.

95% CL:

360 - 630

Mortality:

Group 1 = 0
Group 2 = 3
Group 3 = 1
Group 4 = 1

Clinical signs:

diarrhoea

lethargy (hypoactivity)

other:

Body weight:

lower than 10% body weight loss

Remarks:

There were no remarkable body weight changes for surviving animals.

Other findings:

Macroscopic findings for animals found dead included a distended stomach and yellow matting over the entire ventral surface for one rat each in the 630 mg/kg group.

No macroscopic findings were noted at the scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD0/rat and LD50/rat was found to be 360 and 414 mg/kg bw, respectively.