N,N-dicyclohexylbenzothiazole-2-sulphenamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dicyclohexylbenzothiazole-2-sulphenamide

EC Number:

225-625-8

EC Name:

N,N-dicyclohexylbenzothiazole-2-sulphenamide

Cas Number:

4979-32-2

Molecular formula:

C19H26N2S2

IUPAC Name:

N-(1,3-benzothiazol-2-ylsulfanyl)-N-cyclohexylcyclohexanamine

Details on test material:

Santocure DCBS, lot/batch no: 84/129/01, white powder

Test animals

Species:

rat

Strain:

other: CDr (Sprague-Dawley derivated)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1 % methocel A15C (Dow)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 per sex and dose

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: at 24 hours after application some animals exhibited decrease food consumption, several were hypoactive and a few exhibited other abnormalities

Clinical signs:

other:

Any other information on results incl. tables

Mortality: all animals survived throughout the study (0/10)

Body weight: 3%5 females exhibited slight weight loss at day 7, but all animals gained weight between days 7 and 14.

Pharmacologic and toxicologic signs: most animals were free of abnormalites on day of dosing. However, at 24 hours animals exhibited decrease food consumption, several were hypoactive and a few exhibited other abnormalities

Abnormalities: nasal discharge (1/10 day 6); red nasal discharge (1/10 day 1); oral discharge (1/10 day 1, 1/10 day 7); wet rales (1/10 2 h); ocular discharge (2/10 at day 1); red ocular discharge (1/10 at day 1, 2 and 3); urinary straining (2/10 day 1); unthrifty coat (1/10 at day 1, 2,4, 5, 6 and 7 and 2/10 at day 3; soft stool (1/10 4 h; hypoactivity: 7/10 day 1, 4/10 day 2, 1/19 day 3;food consumption decreased (10/10 day 1, 6/10 day 2, 3/10 day 3, 1/10 day 4; eyes closed 2/10 day 1 and 2). Abnormalities continued in a few animals through day 7 but all animals were free of abnormalities from day 8 through termination of the study (day 14).

Gross postmortem observation: gross postmortem observations were similar to those seen in control animals in this laboratory.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

In a GLP and guideline study with male and female CDR rats no mortality was observed after treatment with 5000 mg/kg bw. Three of the five treated females exhibited slight weight loss at day 7 but all treated animals gained weight between day 7 and termination of the study (day 14). Most animals were free of abnormalities on the day of dosing. However, after 24 hours all animals exhibited decreased food consumption, several were hypoactive and a few exhibited other abnormalities (nasal discharge, oral discharge, wet rales, ocular discharge, urinary straining, unthrifty coat, soft stool, and eyes closed). In addition, no treatment-related gross pathology findings were noted. Based on these findings, the authors concluded that the LD50 of DCBS in rats is greater than 5000 mg/kg bw (Monsanto 1985).