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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)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA-skin sensitisation study does not need to be conducted because adequate data from an in vivo (non-LLNA) study is already available.

Test material

Constituent 1
Reference substance name:
Red 0106-PP1
IUPAC Name:
Red 0106-PP1

In vivo test system

Test animals

Species:
other: Guinea pigs, Ibm: GOHI; SPF

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Remarks:
bi-distilled water
Concentration / amount:
0.1 ml of a 5 % solution of test item in distilled water


1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and

physiological saline

2) test substance diluted to 5% (w/w) in bidistilled water


3) test substance diluted to 5% (w/w) by emulsion in a 1:1

(v/v) mixture of Freund's Complete Adjuvant and

physiological saline


epidermal:

test substance 15% in bidistilled water

Concentration of test material and vehicle used for each challenge:
epidermal:

test substance 15% in bidistilled water
Day(s)/duration:
From day 0 to 7
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
bi-distilled water
Concentration / amount:
0.3 g of a 15 % solution of test item in bi-distilled water, left for 24 hours
Day(s)/duration:
From day 7 to 22
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
bi-distilled water
Concentration / amount:
0.1 ml of a 15 % solution of test item in bi-distilled water


1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and

physiological saline

2) test substance diluted to 5% (w/w) in bidistilled water


3) test substance diluted to 5% (w/w) by emulsion in a 1:1

(v/v) mixture of Freund's Complete Adjuvant and

physiological saline


epidermal:

test substance 15% in bidistilled water

Concentration of test material and vehicle used for each challenge:
epidermal:

test substance 15% in bidistilled water
Day(s)/duration:
24 hours
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Positive control substance(s):
yes
Remarks:
2-MERCAPTOBENZOTHIAZOLE

Results and discussion

Positive control results:
No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occurred.
All 10 test animals showed discrete/patchy to intense erythema and swelling at the 24- and 48-hour reading after the challenge treatment with 2-MERCAPTOBENZOTHIAZOLE at 0.5 % (w/w) in mineral oil.
No skin effect was observed in the control group.

Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EEC, 2-MERCAPTOBENZOïHIAZOLE does have to be classified and labelled as a skin sensitizer.

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
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
10
Total no. in group:
10

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 15 %

Signs of irritation during induction: Possible erythema reaction could not be determined due to substance-related red-brown staining of the skin. However, no oedema was observed.

Evidence of sensitisation of each challenge concentration: 15%: 0/10 animals showed sensitization.

Other observations: None.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not skin sensitising