Dodecyltrimethylammonium bromide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyltrimethylammonium bromide

EC Number:

214-290-3

EC Name:

Dodecyltrimethylammonium bromide

Cas Number:

1119-94-4

Molecular formula:

C15H34N.Br

IUPAC Name:

dodecyltrimethylazanium bromide

Details on test material:

No further details were provided.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Initial body weight (males): 189 - 197 g
Initial body weight (females): 152 - 168 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Doses:

2000, 1000 or 200 mg/kg bw (dose volume of 10 mL/kg body weight)

No. of animals per sex per dose:

One animal per sex per dose: a total of six animals was used, one male and one female for each dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on day 1 (first day of dosing), day 8 and day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic post mortem examination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 1 000 mg/kg bw

Based on:

test mat.

Mortality:

Both animals dosed at 2000 mg/kg bodyweight died, the first animal 2 hours after dosing and the second animal 2 days after dosing. Both animals dosed at 1000 mg/kg body weight died after 2 days of dosing.

Clinical signs:

other: 2000 mg/kg bw: lethargy in 1 animal after 5 minutes of dosing, lethargy in 1 animal and piloerection in 1 animal adrer 2 hours of dosing, absence of reaction 1000 mg/kg bw: lethargy in 1 animal at 5 minutes after dosing, lethargy and piloerction in both

Gross pathology:

Macroscopic post mortem examination of the dead animals dosed at 2000 or 1000 mg/kg body weight revealed brownish fluid stomach content. Macroscopic post mortem examination of female animals dosed at 200 mg/kg body weight revealed irregular areas in the forestomach.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 for oral toxicity of Dodecyltrimethylammonium bromide in both female and male rats is >200 mg/kg bw and <1000 mg/kg bw.

Executive summary:

In an oral toxicity study, Dodecyltrimethylammonium bromide was assessed for its potential to be acutely toxic to Wistar rats. One female and one male rat were exposed to a concentration of 200 mg/kg bw, 1000 mg/kg bw or 2000 mg/kg bw each (six animals in total). Clinical observations were performed in the first 5 minutes, 2 hours and 4 hours after dosing and daily from than onwards until day 15 (14 days after dosing). Bodyweights were measured on day 1 (day of dosing), on day 8 and on day 15. Animals dosed at 2000 mg/kg bodyweight both died; the first animal 2 hours after dosing and the second animal 2 days after dosing. Animals dosed at 1000 mg/kg body weight both died after 2 days of dosing. Macroscopic post mortem examination of the dead animals dosed at 2000 or 1000 mg/kg body weight revealed brownish fluid stomach content and examination of female animals dosed at 200 mg/kg body weight revealed irregular areas in the forestomach. Because no mortality occured at a dose level of 200 mg/kg bw and 100% mortality occured at a dose level of 1000 mg/kg bw, the LD50 of Dodecyltrimethylammonium bromide for both male and female rats is >200 mg/kg bw and <1000 mg/kg bw.