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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Study by GLP compliant laboratory

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Test performed according to Magnusson and Kligman maximisation test
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate
EC Number:
403-500-0
EC Name:
A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate
IUPAC Name:
403-500-0
Constituent 2
Reference substance name:
reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate
IUPAC Name:
reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Concentration of test material and vehicle used at induction:
First induction exposure on day 0: intracutaneous injection of 0.1 ml of a 5% (w/w) solution of the test substance in propylene glycol.
Second induction exposure on day 7: epicutaneous exposure to 0.5 ml of suspension (50% w/w) of the test substance in propylene glycol.

Concentration of test material and vehicle used for each challenge:
50%, 25%, 10% and 0% (w/w) of a suspension of the test substance in propylene glycol.
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Concentration of test material and vehicle used at induction:
First induction exposure on day 0: intracutaneous injection of 0.1 ml of a 5% (w/w) solution of the test substance in propylene glycol.
Second induction exposure on day 7: epicutaneous exposure to 0.5 ml of suspension (50% w/w) of the test substance in propylene glycol.

Concentration of test material and vehicle used for each challenge:
50%, 25%, 10% and 0% (w/w) of a suspension of the test substance in propylene glycol.
No. of animals per dose:
20 animals in test group
Challenge controls:
10 animals in negative control group
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
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: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
15
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 15.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
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: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
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: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
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: 10.0. Clinical observations: no data.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50%.

Signs of irritation during induction:

At the two lower challenge concentrations, over 30% of the animals showed evidence of sensitisation.

Evidence of sensitisation of each challenge concentration:

Sensitisation reactions were characterised by score 2 reaction (moderate but confluent redness) or more severe.

Number of animals showing evidence of sensitisation at each challenge concentration:

50%       12/20

25%       11/20

10%        9/20

3 control animals showed red spots (very light erythema) in reaction to one or two of the concentrations tested.

Other observations:

No consistent signs of systemic toxicity were observed in any of the animals during the study.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The substance is sensitising
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully.