N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2002-05-14 to 2002-10-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides

EC Number:

263-082-9

EC Name:

Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides

Cas Number:

61789-73-9

IUPAC Name:

61789-73-9

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy.
- Age at study initiation: 5 -6 weeks
- Weight at study initiation: 126 to 150 g
- Fasting period before study: Overnight fasting prior to dosing.
- Housing: Housed in groups of 3 animals of the same sex in polycarbonate cages measuring 59 x 20 x 39cm and equipped with a stainless steel mesh lid and floor.
- Diet: ad libitum except for an overnight fast prior to dosing and a period of approximately 4 hours after dosing.
- Water: ad libitum
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 5%
- Air changes (per hr): Not documented
- Photoperiod : 12hrs dark / 12hrs light

IN-LIFE DATES: From: 19th June 2002 To: 12th July 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% (w/v)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: solubility

DOSAGE PREPARATION :
The test item was formulated for dosing by dissolution in an aqueous solution containing 0.5% (w/v) carboxymethylcellulose to give a concentration of 200 mg/ml in terms of test item as received.

CLASS METHOD
- Rationale for the selection of the starting dose: as the oral toxicity was expected to be low, a limit test at one dose level of 2000 mg/kg bw was carried out with 6 animals (3 males in the first step, 3 females in the second step).

Doses:

2000mg/kg

No. of animals per sex per dose:

3 per sex per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs immediately upon dosing, approximately 1, 2 and 4 hours after dosing and daily therafter for a total of 14 days. Body weights were measured at allocation to the study (day -1), immediately prior to dosing (Day 1) and on Days 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

None.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred following dosing at 2000mg/kg in male and female animals.

Mortality:

No mortality occurred following dosing at 2000 mg/kg in both male and female animals.

Clinical signs:

other: - In males, clinical signs were limited to hunched posture on the day of dosing and reduced activity noted from day 2 to 6 of the observation period. - In females, no clinical signs were noted up to day 7. 1 female showed difficulty in breathing, cold to

Gross pathology:

No abnormalities were observed in male or female animals at termination of the study.

Any other information on results incl. tables

Table 1: Body weight summary

	Acute oral toxicity    limit dose level : 2000 mg/kg
	Sex	Body weight in grams
		Day 0	Day 14	Body weight gain (0 -14)
	M	264	348	84
	M	251	311	91
	M	243	290	100
	F	203	230	45
	F	206	148	-36
	F	205	220	47

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC

Conclusions:

Under these experimental conditions, the test material is not classified according to CLP (Reg. n° 1272/2008/EC) and directive 67/548/EEC.

Executive summary:

The objective of this study was to evaluate the toxicity of the test material following a single oral administration in rats according to the OECD guideline 423 and to the EU Method B.1 tris. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.

As the oral toxicity was expected to be low, a limit test at one dose level of 2000 mg/kg bw was carried out with 6 animals,3 males in the first step and 3 females in the second step. The test material was prepared in aqueous solution containing 0.5%(w/v) carboxymethylcellulose and was administered by gavage under a dosage-volume of 10 ml/kg.

Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.

No mortalities occurred in both the male and females. In males, clinical signs were limited to hunched posture and reduced activity but a full recovery was noted by Day 7. In females, no clinical signs were noted up to Day 7 of the observation period but therafter, difficulty in breathing, cold to touch, hunched posture, piloerection and rales were noted in a single animal. Changes in bodyweight observed in treated animals were in general not remarkable and no abnormalities were observed at necropsy.

Under these experimental conditions, the oral LD0 of the test material was equal or higher than 2000 mg/kg bw in rats.