Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study satisfies the criteria established by the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR), the TSCA (40 CFR) and the EEC Council directive. Small deviations from study protocol have been reported, but were considered to not have compromised any aspect of the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
other: Federal Insecticide, Fungicide and Rodenticide Act (40 CFR)
Qualifier:
equivalent or similar to guideline
Guideline:
other: Toxic Substance Control Act (40CFR)
Qualifier:
equivalent or similar to guideline
Guideline:
other: EEC Council directive - not specified
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Available study has been conducted 1990

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide
EC Number:
407-430-1
EC Name:
N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide
Cas Number:
3741-80-8
Molecular formula:
C18H17N3S4
IUPAC Name:
bis(1,3-benzothiazol-2-ylsulfanyl)(tert-butyl)amine
Details on test material:
- Name of test material (as cited in study report): CP22595
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: USDA approved supplier (info taken from study protocol)
Age at study initiation: approx. 5-11 weeks
- Weight at study initiation: 401-622 grams
- Housing: individually housed in wire mesh suspension cages (info taken from study protocol)
- Diet (e.g. ad libitum): ad libitum (info taken from study protocol)
- Water (e.g. ad libitum): ad libitum (info taken from study protocol)
- Quarantine period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80% ethanol / 20% distiled water
Concentration / amount:
50% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80% ethanol / 20% distiled water
Concentration / amount:
50% w/v
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: yes, irritation screening pilot was performed under the following conditions:
Pilot 1: 50%, 25%, 15% and 10% (w/v) of substance in 80% ethanol/20% distilled water
Pilot 2: 50%, 25%, 15% and 10% (w/v) of substance in acetone

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 10 animals
- Control group: 5 animals
- Site: upper left flank
- Frequency of applications: once every seven days
- Concentrations: 50% (w/v) test substance in 80% ethanol/20% water

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction exposure
- Exposure period: 6 hours
- Test groups: 10 animals
- Control group: 5 animals
- Site: lower right flank
- Concentrations: 50% (w/v) test substance in acetone
- Evaluation (hr after challenge): 24 hours after challenge patch removal
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% (w/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (w/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (w/v). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
other: not specified
Group:
positive control
Remarks on result:
other: not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following primary challenge, there were no grades of 1 (or higher) produced in the test or control animals. The incidence and severity of responses in the test group were comparable to those produced by the vehicle control group, indicating that sensitization had not been induced.