(3-methacrylamidopropyl)trimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Study performed before implementation of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Study performance before implementation of the corresponding international OECD guideline 401. However, in consideration of the test institute, it can be anticipated, that study performance complies to a large extent to the later implemented international guideline. The test animals were not fasted before study initiation; in the lower dose group only 3 animals were used.

GLP compliance:

no

Remarks:

Study performed before implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(3-methacrylamidopropyl)trimethylammonium chloride

EC Number:

257-182-1

EC Name:

(3-methacrylamidopropyl)trimethylammonium chloride

Cas Number:

51410-72-1

Molecular formula:

C10 H21 N2 O. Cl

IUPAC Name:

trimethyl-[3-(2-methylprop-2-enoylamino)propyl]azanium chloride

Test material form:

other: aqueous solution

Details on test material:

- Name of test material (as cited in study report): Methylacrylamidopropyltrimethylammonium chloride, MAPTAC

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan
- Age at study initiation: no data
- Weight at study initiation: 90 to 120 g
- Fasting period before study: nonfasted
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- no vehicle

MAXIMUM DOSE VOLUME APPLIED:
- no data

DOSAGE PREPARATION (if unusual):
- no data

Doses:

5.0, 10.0 mL/kg

No. of animals per sex per dose:

3 for 5.0 mL/kg dose group, 10 for 10.0 mL/kg dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on day 1 and at termination; observation of clinical signs 0-6 h, 6-24 h, days 2, 3, 4, 5, 6, 7, 8-14
- Necropsy of survivors performed: yes
- Other examinations performed: no data

Statistics:

none

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 600 mg/kg bw

Based on:

other: product

Remarks on result:

other: mortality 1/10; recalculation to mg/kg bw with density=1.06 g/cm³

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 240 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: mortality 1/10; recalculation to mg/kg bw with density=1.06 g/cm³

Mortality:

- 0/3 died in the 5.0 mL/kg dose group
- 1/10 died in the 10.0 mL/kg dose group within in first 6 hours after application

Clinical signs:

other: - all animals were sluggish in the 10.0 mL/kg dose group within the first 6 hours after application, the survivors had recovered on day 2 - no signs in the 5.0 mL/kg dose group

Gross pathology:

All survivors appeared normal.
In the dead animal the stomach was transparent and filled with liquid; the intestines appeared pink and injected.

Other findings:

none reported

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

On the basis of the results obtained after a single oral administration, the oral LD50 was determined to be > 10600 mg/kg body weight based on product, corresponding to approximately > 4240 mg/kg bw referring to 100 % active ingredient.

Executive summary:

In an acute oral toxicity study, groups of nonfasted male Wistar ratswere given a single oral dose of MAPTAC (40% by weight in water) at doses of  5.0 and 10.0 mL/kg bw corresponding to 5300 and 10600 mg/kg bw, respectively based on a density of 1.06 g/cm³, and observed for 14 days. 3 animals in the lower dose group and 10 animals in the higher dose group were used.

No mortality occurred in the 5 mL/kg dose group; 1/10 died in the 10.0 mL/kg dose group. Sluggishness was observed in the higher dose group up to 6 hours after dosing, but all surviving animals had recovered on day 2. No abnormalities were observed at necropsy in the surviving animals.

Oral LD50 Males > 10600 mg/kg bw

The LD50 determined refers to the test substance as delivered by the sponsor. The amount of active ingredient in the test substance is 40%. Therefore the calculated oral LD50 referring to 100% active ingredient is > 4240 mg/kg bw.

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