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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and 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 81-5 (Acute Dermal Irritation)
Principles of method if other than guideline:
Method: other: exposure time: 24 h (no further data)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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
Test material form:
solid: particulate/powder
Remarks:
Off-white
Details on test material:
Santocure DCBS
- Analytical purity: > 96%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 and 24 h
Observation period:
up to 72 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
other: 4 h treatment
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
other: 4 h treatment
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 24 h treatment
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Remarks on result:
other: 24 h treatment
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
8
Reversibility:
other: 4 h treatment no effects
Remarks on result:
other: 4 h treatment
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: 24 h treatment

Any other information on results incl. tables

The test substance DCBS was essentially non-irritating to the skin. The only irritation seen was transient very slight (barely perceptible) erythema in one animal at the sites exposed for 24 hours under occlusive covering. This animal was free of irritation at both sites by day 7. The primary irritation index for the 24 -hour exposures was 0.1.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP and EPA Guideline study with New Zealand White rabbits, the dermal application of 0.5 g of the solid test substance DCBS to 6 animals for 4 and 24 hours was essentially non-irritating to the skin. The only irritation seen was transient very slight (barely perceptible) erythema in one animal at the sites exposed for 24 hours under occlusive covering. This animal was free of irritation at both sites by day 7. The primary irritation index for the 24 -hour exposures was 0.1 (Monsanto Co. 1985).