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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzothiazole-2-thiol
EC Number:
205-736-8
EC Name:
Benzothiazole-2-thiol
Cas Number:
149-30-4
Molecular formula:
C7H5NS2
IUPAC Name:
1,3-benzothiazole-2-thiol
Details on test material:
2-mercaptobenzothiazole, batch no. 01631-077 (supplied by Aldrich Chemie), purity not reported

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HSD Poc:DH strain
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 5 % (= 20 mg test item/animal) topical induction: 25 % (= 125 mg test item/animal), challenge: 12 % (= 60 mg test item/animal)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 5 % (= 20 mg test item/animal) topical induction: 25 % (= 125 mg test item/animal), challenge: 12 % (= 60 mg test item/animal)
No. of animals per dose:
treatment group: 10, neagitve control: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12 %
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
Appearance and behavior of the test item group were not different from control group
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: Appearance and behavior of the test item group were not different from control group.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
12 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
Appearance and behavior of the test item group were not different from control group
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Appearance and behavior of the test item group were not different from control group.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.

Any other information on results incl. tables

At the end of the study , the mean body weight of the treatment group animals was slightly higher than that of the control group animals.

The total number of animals with skin reactions was 70 % in the test substance group and 20 % in the control group.

Applicant's summary and conclusion