Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.6 (Bühler-Test)
GLP compliance:
yes
Type of study:
other: Traditional sensitisation test
Justification for non-LLNA method:
Traditional sensitisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-mercaptobenzothiazolyl-(Z)-(2-aminothiazol-4-yl)-2-(tert-butoxycarbonyl) isopropoxyiminoacetate
EC Number:
419-040-9
EC Name:
2-mercaptobenzothiazolyl-(Z)-(2-aminothiazol-4-yl)-2-(tert-butoxycarbonyl) isopropoxyiminoacetate
Cas Number:
89604-92-2
Molecular formula:
C20H22N4O4S3
IUPAC Name:
tert-butyl 2-{[(Z)-[1-(2-amino-1,3-thiazol-4-yl)-2-(1,3-benzothiazol-2-ylsulfanyl)-2-oxoethylidene]amino]oxy}-2-methylpropanoate

In vivo test system

Test animals

Species:
other: gpg

Study design: in vivo (non-LLNA)

Induction
Route:
other: not available
Vehicle:
petrolatum
Concentration / amount:
40%
Challenge
Route:
other: n.a.
Vehicle:
petrolatum
Concentration / amount:
40%
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40%
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 40 %

Signs of irritation during induction:

keine

"ENGLISH"

none

Evidence of sensitisation of each challenge concentration:

keine

"ENGLISH"

none

Other observations:

keine

"ENGLISH"

none

Applicant's summary and conclusion

Interpretation of results:
other: not classified