Ethyldimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl]ammonium ethyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February-March, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

METHACRYLOYLDIMETHYLETHYLAMMONIUMETHYLSULFATE, 39 .6% AQUEOUS FORMULATION

SUBSTANCE NUMBER: 94/521

LOT NUMBER: PARTIE 7/94

DATE OF MANUFACTURING: 10-SEP-1994

PHYSICAL STATE/APPEARANCE : LIQUID, ACHROMATIC

Specific details on test material used for the study:

METHACRYLOYLDIMETHYLETHYLAMMONIUMETHYLSULFATE, 39 .6% AQUEOUS FORMULATION

SUBSTANCE NUMBER: 94/521

LOT NUMBER: PARTIE 7/94

DATE OF MANUFACTURING: 10-SEP-1994

PHYSICAL STATE/APPEARANCE : LIQUID, ACHROMATIC

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

ANIMAL SPECIES : RAT / WISTAR / CHBB : THOM (SPF)

ANIMAL BREEDER : DR . K . THOMAE GMBH, BIBERACH, FRG

AGE OF THE ANIMALS : YOUNG ADULT ANIMALS .

ANIMAL WEIGHTS AT START OF THE STUDY : ANIMALS OF COMPARABLE WEIGHT ; (150G - 300G) (+- 20$ OF THE MEAN WEIGHT) .

ANIMAL IDENTIFICATION : INDIVIDUAL IDENTIFICATION USING CAGE CARDS AND GROUP IDENTIFICATION BY TAIL MARKING .

ROOM TEMPERATURE/RELATIVE HUMIDITY : THE ANIMALS WERE HOUSED IN FULLY AIR-CONDITIONED ROOMS . CENTRAL AIR-CONDITIONING GUARANTEED A RANGE OF 20 - 24 DEGREES CELSIUS FOR TEMPERATURE AND OF 30 - 70 $ FOR RELATIVE HUMIDITY . THERE WERE NO DEVIATIONS FROM THESE RANGES WHICH INFLUENCED THE RESULTS OF THE STUDY .

DAY/NIGHT RHYTHM : 12 H/12 H(6 .00 A .M . - 6 .00 P .M / 6 .00 P .M . - 6 .00 A .M . )

TYPE OF CAGE : STAINLESS STEEL WIRE MESH CAGES, TYPE DK-III (BECKER 6 CO ., CASTROP-RAUXEL, FRG )

NO . OF ANIMALS PER CAGE : SINGLE HOUSING .

BEDDING : NO BEDDING IN THE CAGES ; SAWDUST IN THE WASTE TRAYS .

DRINKING WATER : TAP WATER AD LIBITUM PER DAY .

DIET : KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND ,
AD LIBITUM .

ANALYSIS OF DRINKING WATER : THE DRINKING WATER IS REGULARLY ASSAYED FOR CHEMICAL CONTAMINANTS BY THE MUNICIPAL AUTHORITIES OF FRANKENTHAL AND THE TECHNICAL SERVICES OF BASF AKTIENGESELLSCHAFT AS WELL AS FOR THE PRESENCE OF GERMS BY A CONTRACT LABORATORY .

ANALYSIS OF FEED : THE FEED USED IN THE STUDY WAS ASSAYED FOR CHEMICAL AND MICROBIOLOGICAL CONTAMINANTS .

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

SINGLE ORAL ADMINISTRATION BY GAVAGE .

Doses:

2 dose level groups: Dose levels 200 and 2000 mg/kg b.w.

Administration volume 10 mL/kg b.w.

No. of animals per sex per dose:

Number of animals = 3 males and/or 3 females

Control animals:

no

Details on study design:

THE ANIMALS WERE GIVEN NO FEED AT LEAST 16 HOURS BEFORE ADMINISTRATION, BUT WATER WAS AVAILABLE AD LIBITUM .

TIME OF DAY OF ADMINISTRATION : IN THE MORNING .

OBSERVATION PERIOD : 14 DAYS

BODY WEIGHT DETERMINATION : INDIVIDUAL BODY WEIGHTS SHORTLY BEFORE APPLICATION (DAY 0), WEEKLY THEREAFTER AND AT THE END OF THE STUDY (BEFORE FASTING PERIOD) .

SIGNS AND SYMPTOMS : RECORDING OF SIGNS AND SYMPTOMS SEVERAL TIMES ON THE DAY OF ADMINISTRATION, AT LEAST ONCE EACH WORKDAY FOR THE INDIVIDUAL ANIMALS ; THESE RECORDS ARE MAINTAINED WITH THE RAW DATA.

GENERAL OBSERVATIONS AND A CHECK WAS MADE TWICE EACH WORKDAY AND ONCE ON MORTALITY : SATURDAYS, SUNDAYS AND ON PUBLIC HOLIDAYS FOR GENERAL OBSERVATIONS AND FOR ANY DEAD OR MORIBUND ANIMALS

PATHOLOGY : NECROPSY AT THE LAST DAY OF THE OBSERVATION PERIOD. WITHDRAWAL OF FOOD AT LEAST 16 HOURS BEFORE KILLING WITH C02 ; THEN NECROPSY WITH GROSSPATHOLOGY EXAMINATION . NECROPSY OF ALL ANIMALS THAT DIED BEFORE AS EARLY AS POSSIBLE .

Statistics:

No statistical analysis was performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No clinical signs

Gross pathology:

No signs of abnormalities were noted at necropsy at any dose level.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the range of mortality of the test substance after oral application was found to be greater than 2000 mg/kg body weight for male and female animals. The LD0 was 2000 mg/kg and the LD 50 was greater than 2000 mg/kg.