3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile

EC Number:

274-668-9

EC Name:

3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile

Cas Number:

70546-25-7

Molecular formula:

C21H17N3O2S

IUPAC Name:

3-(1,3-benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-chromene-4-carbonitrile

Test material form:

solid

Specific details on test material used for the study:

Name: Macrolex Fluoreszenz Rot G

Chemical name: 2H-1-Benzopyran-4-carbonitri le,3-(2-benzothiazolyt-7-(oliethylamino)-2-oxo-

CAS-Number: 70546-25-7

Molecular formula: C12H11N3O2S

Molecular weight: 375 g/mol

Specific gravity: 0.24-0.29 kg/I

Certificate of analysis dated June 24, 1996

Purity: 100 % technical pure

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age at the start of the study: male animals approximately 7 weeks female animals approximately 8 weeks

Body weights: males: mean = 179 g; females:mean = 167 g
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) an soft wood granulate in groups of 5


Room temperature: 22 ± 3°c
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily at least one day
Food: ssniff® R/M-H (V 1534), ad libitum

Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment

Water: tap water in plastic bottles, ad libitum

Animal identification: fur marking with KMnO4 and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Details on oral exposure:

Macrolex Fluoreszenz Rot G was suspended in the stated concentration in sesame oil and distributed homogeneously by means of a magnetic stirrer.

The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males; 5 females

Control animals:

no

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no

Clinical signs:

other: The following clinical signs were observed after the administration of Macrolex Fluoreszenz Rot G: irregular respiration, stilted and uncoordinated gait, squatting posture, diarrhea and dark-colored feces.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Based on the results obtained in this study the median lethal dose value (LD50) of Macrolex Fluoreszenz Rot G for the male and female Wistar rat is greater than 2000 mg/kg body weight. No aniamls died at 2000 mg/kg, consequently this dose is considered to be the LD(0).