Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diallydimethylammonium chloride (64.3% solution in water).
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): 1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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 levelsopen allclose all
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
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
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:
Piloerection, ataxia, reduce motor activity, body tremor, death.
Body weight:
Group Mean body Weight day 0 Mean body Weight day 14
I 176.5 g 202.5 g
II 175.5 g 200.4 g
III 175.0 g 202.5 g
IV 175.0 g not weighed
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.