(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1981

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

EC Number:

261-684-6

EC Name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Cas Number:

59272-84-3

Molecular formula:

C21H42N2O3

IUPAC Name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Cpb:WU; Wistar random

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: young adult
- Weight at study initiation: males: 140 - 164 g; females: 112 - 156 g
- Fasting period before study: overnight before treatment until 4 hours after teatment
- Housing: groups of five, males and females separated in stainless steel cages with grid-bottom
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1°C
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%(w/v)

Doses:

1493, 1793, 2150, 2580, and 3095 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After treatment, the rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and thereafter at least once daily throughout a 14-day observation period. The individual body weights were determined on Day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights

Statistics:

The LD50 was calculated according to the method of C.S. Weil (Biometrics 8 (1952), 249-263)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 875 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 670 - <= 2 105

Mortality:

Deaths occurred between 6 hours and 3 days after treatment (see table 1 for details). Then the survivors recovered gradually and looked quite healthy again at the end of the observation period.

Clinical signs:

Clinical observations during the first 4 post—treatment hours revealed sluggishness, humpback behaviour, rough coats and slight diarrhoea. Later on soiled coats and signs of emaciation were observed.

Body weight:

The individual body weights of the survivors on Days 0, 7 and 14 indicated body weight gain within the expected range for this species and strain.

Gross pathology:

Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alteration.

Any other information on results incl. tables

Table 1: Mortality and body weight

Dose		Mean body weight [g] on day						Mortality
Test solution [mL/kg bw]	Test substance [mg/kg bw]	0	7	14	0	7	14	Dead out of 5
		males			females			males	females
5.97	1493	152	192	211	124	141	164	0	2
7.17	1793	161	196	222	125	-	-	0	5
8.60	2150	153	189	223	149	194	227	3	3
10.32	2580	153	-	-	129	-	-	5	5
12.38	3095	149	-	-	132	-	-	5	5

Applicant's summary and conclusion

Interpretation of results:

other: Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008