Diallyldimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Pre-GLP

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diallyldimethylammonium chloride

EC Number:

230-993-8

EC Name:

Diallyldimethylammonium chloride

Cas Number:

7398-69-8

Molecular formula:

C8H16N.Cl

IUPAC Name:

diallyldimethylammonium chloride

Details on test material:

Diallydimethylammonium chloride (64.3% solution in water).

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Age at study initiation: unknown
- Weight at study initiation: 180 g
- Fasting period before study: 18-20h
- Housing: individual cages
- Diet: ad libitum (Saniff/Intermast)
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS: no data given
IN-LIFE DATES: Unknown

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0, 3.18, 3.98, 5.00 and 6.30 ml/kg

No. of animals per sex per dose:

5 males/5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 15, 30, 60, 120, and 240 minutes after dosing and daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, gross pathology

Statistics:

The LD50 was calculated according to the method of "Thomson and Weil" (Biometrics 8, 51-54, 1952) at 24h and 14 days.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

3.18 mL/kg bw

Based on:

test mat.

Remarks on result:

other: 2044 mg/kg bw effecrtive dose

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4.81 mL/kg bw

Based on:

test mat.

95% CL:

> 4.41 - <= 5.53

Remarks on result:

other: 3093 mg/kg bw effective dose

Effect levels 3

Sex:

male/female

Dose descriptor:

LD100

Effect level:

6.3 mL/kg bw

Based on:

test mat.

Remarks on result:

other: 4047 mg/kg bw effective dose

Mortality:

Mortality was as follows:
Group     Dose (ml/kg)         1 day mortality     14 day mortality
I               3.18                        0/10         0/10
II              3.98      1/10         1/10
III             5.00    6/10         6/10
IV            6.30       10/10   10/10

Clinical signs:

other: Piloerection, ataxia, reduce motor activity, body tremor, death.

Gross pathology:

All animals showed a high hyperemia of the epithelium of the stomach, jejunum and colon.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for the 63% solution of DADMAC was calculated as 4.81 (4.41-5.53) ml/kg which is the equivalent of 3093 DADMAC mg/kg bw. The No Observed Adverse Effect Level was 3.18 ml/kg bw, equivalent to 2044 mg DADAMAC/kg bw.