(3-chloro-2-hydroxypropyl)trimethylammonium chloride

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:

other: Study well documented, meets generally accepted scientific pinciples

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Principles of method if other than guideline:

Method: other: LD50 was calculated according to the method of Weil (Biometrics 8 (1952), 249-263)

Method similar to the (now deleted) OECD 401.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloro-2-hydroxypropyl)trimethylammonium chloride

EC Number:

222-048-3

EC Name:

(3-chloro-2-hydroxypropyl)trimethylammonium chloride

Cas Number:

3327-22-8

Molecular formula:

C6H15ClNO.Cl

IUPAC Name:

3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride

Details on test material:

IUCLID4 Test substance: other TS: Servon XRK 60 (no further data)

Test animals

Species:

rat

Strain:

other: SPF-bred albino rats (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, NETHERLANDS.
- Weight at study initiation: 84-116 g (males); 76-100 g (females)
- Fasting period before study: not stated
- Housing: stainless steel cage (numer/cage not stated)
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1
- Humidity (%): no data
- Air changes (per hr): 'well ventilated'
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: undiluted

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:


MAXIMUM DOSE VOLUME APPLIED:

Doses:

1.92, 2.30, 2.76, 3.31, 3.98 mg/kg body weight

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: weighed on days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 according to: Weil (1952). Biometrics 8, 249.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3.2 mL/kg bw

95% CL:

2.66 - 3.84

Remarks on result:

other: 60% CHPTAC

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 688 mg/kg bw

Remarks on result:

other: 60% CHPTAC

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 213 mg/kg bw

Remarks on result:

other: 100% CHPTAC

Mortality:

See table 1.

Clinical signs:

other: No clinical signs amongst survivors.

Gross pathology:

No abnormal gross pathology.

Other findings:

None reported.

Any other information on results incl. tables

Table 1: Mortality

Dose (ml/kg bw)	Mortality (dead/total)
	Male	Female	Combined
1.67	1/5	0/5	1/10
2.00	0/5	1/5	1/10
2.40	2/5	1/5	3/10
2.88	4/5	3/5	7/10
3.46	4/5	2/5	6/10

Death occurred within 1 h of dosing; survivors recovered and there were no overt signs of toxicity. No gross abnormalities were identified on examination.

LD₅₀ (Servon XRK 60) = 3.20 ml/kg bw. or 3.68 g/kg bw (TS specific gravity 1.15)

Equivalent to an LD₅₀  for 100% CHPTAC of 2213 mg/kg bw/day

Applicant's summary and conclusion

Conclusions:

A reliable study conducted very largely in compliance with a standard guideline but without GLP, identified an LD50 value for 60% CHPTAC of 3.20 ml/kg bw in male and female rats. This would be equivalent to an LD50 for 100% CHPTAC of 2213 mg/kg bw.