N,N-dicyclohexylbenzothiazole-2-sulphenamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 81-2 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute 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

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 h

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: most animals were free of signs of systemic toxicity, although several occurences of nasal discharge were seen

Clinical signs:

other:

Any other information on results incl. tables

Mortality: all animals survived throughout the study, therefore the dermal LD50 of DCBS is greater than 5000 mg/kg bw

Body weight: most animals exhibited little or no weight change at day 7, but all gained weight between days 7 and 24.

Pharmacologic and toxicologic signs: most animals were free of signs of systemic toxicity, although several occurences of nasal discharge were seen, primarily in a single animal, and a few occurences of ocular irritation were noted in another animal.

Gross postmortem observations: Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The acute dermal toxicity of the test substance DCBS was evaluated with New Zealand White rabbits in a GLP and guideline study. Moistened test substance was applied for 24 h directly to the clipped intact skin of New Zealand White rabbits at a dose of 5000 mg/ kg bw (5 males and 5 females.). A 14-day observation period followed application. No mortality was observed. Most animals were free of signs of systemic toxicity, although several occurrences of nasal discharge were seen, primarily in a single animal, and a few occurrences of ocular irritation were noted in another animal. Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation. Based on these findings the authors concluded that the LD50 is greater than 5000 mg/kg bw (Monsanto 1985).