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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This in vivo study was conducted in 1999, before publication of Commission Regulation (EU) 2017/706.

Test material

Constituent 1
Reference substance name:
Registered substance
IUPAC Name:
Registered substance

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction: Induction intradermale: 0.1 ml 1) solution FCA : saline physiological (50:50) 2) 5% (v/v) substance in distd. water 3) 5% (v/v) substance in solution FCA : saline physiological (50:50) epidermal Induction: 0.3 ml of 15%(v/v) substance in distd. water. Concentration of test material and vehicle used for each challenge: epidermal challenge: 25% (v/v) substance in distd. water.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction: Induction intradermale: 0.1 ml 1) solution FCA : saline physiological (50:50) 2) 5% (v/v) substance in distd. water 3) 5% (v/v) substance in solution FCA : saline physiological (50:50) epidermal Induction: 0.3 ml of 15%(v/v) substance in distd. water. Concentration of test material and vehicle used for each challenge: epidermal challenge: 25% (v/v) substance in distd. water.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Challenge controls:
No skin reactions were observed in the animals when treated with bi-distilled water only. Blue discoloration was noted directly after removal of the patch. To
remove discoloration all animals were depilated approximately 3 hours prior to challenge reading.
Positive control substance(s):
yes
Remarks:
2- MERCAPTOBENZOTHIAZOLE

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15 % (v/v)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15 % (v/v). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15 % (v/v)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15 % (v/v). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15 % (v/v)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 15 % (v/v). No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15 % (v/v)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 15 % (v/v). No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not relevant for classification;