Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
acute oral toxicity after single application
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
EC Number:
271-756-9
EC Name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
Cas Number:
68607-24-9
Molecular formula:
The substance is a quarternary ammonium chloride derived from fatty alcohol. The general chemical structure is R-N(Me)3+ Cl-, whereas the alkylrest R is variable for the main components C20 and C22 but also shorter and longer C-Chains (in smaller amounts)
IUPAC Name:
N,N,N-trimethyl-C20-22-(even numbered)-alkyl-1-aminium chloride
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst
- Age at study initiation: no data
- Weight at study initiation: 82-104 g (mean 93 g )
- Fasting period before study: 16 h
- Housing: in plastic cages
- Diet (e.g. ad libitum): Standard Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): dependent on dose, not constant
- Justification for choice of vehicle: not given

MAXIMUM DOSE VOLUME APPLIED: 50 ml/kg

Doses:
800 mg/kg
1250 mg/kg
2000 mg/kg
3200 mg/kg
5000 mg/kg
No. of animals per sex per dose:
10 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing once per week
- Necropsy of survivors performed: unclear from report
- Other examinations performed: body weight, no further information
Statistics:
LD50 was calculated using Probit analysis

Results and discussion

Preliminary study:
No sex differences were observed in preliminary study, therefore only females were used in the main study
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 190 mg/kg bw
Mortality:
The following number of deaths were observed per dose group:
dose (mg/kg) -- number of death animals -- number of total animals
800 -- 0 -- 10
1250 -- 0 -- 10
2000 -- 1 -- 10
3200 -- 5 -- 10
5000 -- 10 -- 10
Clinical signs:
not reported
Body weight:
body weights are reported but results were not analysed or commented
Gross pathology:
unclear if done

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of 3190 mg/kg was obtained for the registration substance.
Executive summary:

The registration substance was given to female rats (n = 10 per dose) via gavage at doses of 800, 1250, 2000, 3200 and 5000 mg/kg. No death occured at 800 and 1250 mg/kg. One, five and ten rats died at 2000, 3200 and 5000 mg/kg respectively. The LD50 of 3190 mg/kg was obtained.