Didecyldimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Didecyldimethylammonium chloride

EC Number:

230-525-2

EC Name:

Didecyldimethylammonium chloride

Cas Number:

7173-51-5

Molecular formula:

C22H48N Cl

IUPAC Name:

didecyldimethylammonium chloride

Details on test material:

Test substance: as prescribed by 1.2 as typical marketed substance (act:50%, ipa:20%, water: 30%)
Composition: The test substance contains approx. 50% didecyldimethylammonium chloride (CAS no.: 7173-51-5) and 20% isopropanol (CASno.: 67-63-0) in water
Lot no.: 93711

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species: Rat
Strain: Wistar (outbred SPF-Quality)
Source: BRL Ltd., Basel, Switserland
Sex: Male - 5, female - 5
Age/weight at study initiation:
group 1: Approx. 11 wks ; 235-265 g (males) and 183-211 g (females)
group 2&3: Approx. 8 wks; 197-260 g (males) and 182-200 g (females)
Number of animals per group: 5 male and 5 female / dose group
Control animals: Yes

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: undiluted test material

Details on oral exposure:

Post-exposure period: 14 days
Type: Gavage
Concentration 2000 (group 1), 1000 (group 2) and 500 (group 3) mg/kg bw
(1000, 500 and 250 mg active ingredient/kg bw)
Concentration in vehicle: Undiluted test material, containg ca. 50% active material
Total volume applied; Group 1: 2.273 ml/kg; Group 2: 1.136 mL/kg; Group 3: 0.568 mL/kg
Controls: No control group
Examinations; Mortality, body weights, clinical signs and Gross necropsy for any macroscopic abnormalities

Doses:

500, 1000 and 2000 mg/kg bw.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

Refer to details on oral exposure

Statistics:

No data

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 329 mg/kg bw

Based on:

act. ingr.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

406 mg/kg bw

Based on:

act. ingr.

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

264 mg/kg bw

Based on:

act. ingr.

Mortality:

The mortality incidence for both sexes combined for high, mid and low dose group was 10/10, 9/10 and 2/10.

Clinical signs:

other: Effects noted following treatment were lethargy, piloerection, dyspnoea, rattled respiration, staggering gait and bloody eye/nose encrustation. The surviving animals recovered between days 8 and 15.

Gross pathology:

Necropsy of the decedents revealed mainly haemorrhages/red areas in glandular stomach or forestomach; discolouration of the stomach or intestinal content; irregular areas in the forestomach and adherence of spleen, pancreas, serosa of the forestomach, left lateral liver lobe and diaphragm to each other.
Animals that survived to the end of the study showed mainly the same effects.

Any other information on results incl. tables

LD50 combined = 658 mg/kg bw (i.e. 329 mg a.i./kg bw)

LD50, males = 812 mg/kg bw
LD50, females = 527 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

other: Category 4

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The combined acute oral LD50 of the test substance in Wistar rats was determined to 658 mg/kg bw (i.e. 329 mg a.i./kg bw) in males and females.

Executive summary:

An acute oral toxicity was performed in Wistar rats according to OECD Guideline 401 under GLP conditions. The test substance was orally gavaged once to 5 males and 5 female rats per group at doses of 250, 500 and 1000 mg a.i./kg bw. The post-exposure period was 14 days. The examinations performed included mortality, body weights, clinical signs and gross necropsy for any macroscopic abnormalities. The mortality incidence in both sexes combined for high, mid and low dose groups were 10/10, 9/10 and 2/10. Necropsy of the decedents revealed mainly haemorrhages/red areas in glandular stomach or forestomach; discolouration of the stomach or intestinal content; irregular areas in the forestomach and adherence of spleen, pancreas, serosa of the forestomach, left lateral liver lobe and diaphragm to each other. Animals that survived to the end of the study showed similar effects. The combined oral LD50 of the test substance in Wistar rats was determined to be 658 mg/kg bw (i.e., 329 mg a.i./kg bw) in males and females.