2,3-epoxypropyltrimethylammonium 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 largely equivalent to the guideline study, without GLP status, meeting generally accepted scientific principles and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

Method: other
Largely in compliance with a standard guideline (OECD 401, now deleted).

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropyltrimethylammonium chloride

EC Number:

221-221-0

EC Name:

2,3-epoxypropyltrimethylammonium chloride

Cas Number:

3033-77-0

Molecular formula:

C6H14NO.Cl

IUPAC Name:

N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride

Details on test material:

Test substance: Quab 151, 71.9 % aqueous solution

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

ENVIRONMENTAL CONDITIONS
No details available.



TEST ANIMALS
- Source: TNO. Central Institute for the breeding of laboratory animals, Zeist, NETHERLANDS
- Weight at study initiation: 194-256 g (m); 120-183 g (f)
- Fasting period before study: overnight fast before dosing
- Housing: 5/grid-bottomed stainless steel cage
- Diet: standard ad libitum
- Water: drinking water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/-1

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% EPTAC in water (EPTAC is itself 71.9% TS in aqueous solution)

MAXIMUM DOSE VOLUME APPLIED: 8.5 ml/kg bw

Doses:

4.0, 4.8, 5.8, 6.9 and 8.5 ml/kg bw in aqueous solution (see method below)

No. of animals per sex per dose:

5

Control animals:

other:

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not stated
- Necropsy of survivors performed: yes
- Other examinations performed: not stated

Statistics:

Method of Weil.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 088 mg/kg bw

Remarks on result:

other: converted for pure EPTAC

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1.34 mL/kg bw

95% CL:

1.18 - 1.52

Remarks on result:

other: 71.9% EPTAC

Mortality:

See table 1 below

Clinical signs:

other: See Remarks on Results, below.

Gross pathology:

See Remarks on Results, below.

Any other information on results incl. tables

Table 1: Number of animals dead

Dose (ml 20% EPTAC/kg bw)	Mortality (dead/total)
	Male	Female	Combined
4.0	0/5	1/5	1/10
4.8	1/5	1/5	2/10
5.8	1/5	2/5	3/10
6.9	0/5	4/5	4/10
8.5	4/5	5/5	9/10

 

Within few hours of dosing, the rats showed sedation, dark-coloured eyes, tremors and convulsions. No details were given about the doses at which the non-lethal effects occurred. Later, diarrhoea and loss of consciousness was observed. The animals died between 1 and 48 hours. The surviving animals appeared to have recovered at the end of the observation period. When observed macroscopically, animals had no treatment-related alterations. An LD50 value of 1.34 ml/kg (CI 95% 1.18 and 1.52) for the 71.9% test substance was calculated according to the method of Weil. This can be converted to approximate milligrams using the density value of 1129 mg/cm3 available for 70% EPTAC. The resulting LD50 is 1513 mg/kg of the 71.9% test substance or 1088 mg/kg bw pure EPTAC.

[IUCLID 4 gave 1080 mg/kg bw, as taken from the RAR 2008 summary. The text of the RAR suggests 1088 mg/kg bw to be the correct value. This is confirmed when the full report that was provided.]

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted very largely in compliance with a standard guideline but without GLP, identified an LD50 value of 1088 mg/kg bw in male and female rats, derived from a value of 1513 mg/kg bw for the 71.9% aqueous test substance.