Acetamide, N-(2-amino-4,5,6,7-tetrahydro-6-benzothiazolyl)-, hydrobromide (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide

EC Number:

600-588-4

Cas Number:

104617-50-7

Molecular formula:

C9 H13 O N3 S x HBr

IUPAC Name:

N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide

Test animals

Species:

rat

Strain:

other: Albino rats, Chbb:THOM

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Experimental Animal Breeding Centreof Dr. karl Thomae GmbH, Biberach
- Age at study initiation: 47-54 days
- Weight at study initiation: 163.5 - 182.3 g

- Housing: conventional accommodation in the room No. 218 of the small animal house I; individual accommodation in type III Makrolon cages with softwood granulate bedding

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): filtered, demineralized water, adjusted to pH 2.6 +/- 0.2 with hydrochloric acid
- Acclimation period: 5 days
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups: the animals were code-marked in groups by ear-piecing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deg C, +3, -1
- Humidity (%): ca. 55%
- Photoperiod (hrs dark / hrs light): 12 hrs (light 6 to 18)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

with 0,1% Tween 80

Details on oral exposure:

The single peroral administration was performed with Ulra Asept syringe and a stomach tube.

The day of administration counted day 1 for each treated animal

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male + 5 female

Control animals:

not specified

Details on study design:

on the first day of the study (day 1 = day of the treatment) the animals were observed throughout the working day. Thereafter, up to the 14th day, they were observed twice daily (in the morning and in the after­ noon). On weekends and holidays they were observed once daily (in the morning). Behaviour changes and toxic symptoms were recorded in group protocols.

All study animals were weighed one day before the study start (day -1 = fasting day) and before treatment. The surviving animals were weighed on the 8th and 15th study day.

The increase of the body weight per group was calculated for each trial week.

After a 14 day observation period, the surviving animals were exsanguinated under deep Pentobarbital narcosis (40 mg/kg,
i.p. injection), autopsied and examined macroscopically. All findings were recorded in autopsy group protocols.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

there were no deaths

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

the body weight development of the animals was not influenced by the substance administration.

Gross pathology:

At the autopsy of the surviving animals at the end of the study, no macroscopic organ or tissue damage were recorded.

Applicant's summary and conclusion

Interpretation of results:

other: acc. CLP "not classified"

Conclusions:

The compound 2-Amino-6-acetylamino-4,5,6,7-tetrahydrobenzothiazol* HBr (Precursor 1 of SND 919 CL2 Y) revealed a very low acute toxicity
after peroral administration in rats, as can be documented by the maximal nonlethaI dose established:
- Maximal nonlethaI dose: male and female : 2000 mg/kg
With an approximate LD50 » 2000 mg/kg after oral administration in rats the compound 2-Amino-6-acetylamino-4,5, 6,7-tetrahydrobenzo-thiazol*HBr(Precursor 1 of SND 919 CL2 Y) could be classified as nontoxic according to the "Chemikaliengesetz"c(German Chemicals Act).
Thus no labelling with an R-phrase regarding the accidental ingestion is necessary.