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Diss Factsheets

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
intracutaneous test
Justification for non-LLNA method:
Testing was completed in the 1960's before the LLNA method was available.

Test material

Constituent 1
Reference substance name:
di-isopropyl xanthogen disulphide (DIXD)
IUPAC Name:
di-isopropyl xanthogen disulphide (DIXD)

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: 1:1 acetone-dioxane in 13% guinea pig fat
Concentration / amount:
0.1ml of the 0.5% solution
Day(s)/duration:
14 and 21 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: 1:1 acetone-dioxane containing 13% guinea pig fat (f.a.d.)
Remarks:
1, 1, 2 and 6 appplications were made over a 3-week period
Concentration / amount:
1 drop of test solution was diluted in 1:1 acetone-dioxane in 13% guinea pig fat (f.a.d.)
Day(s)/duration:
21 days
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: 1:1 acetone-dioxane containing 13% guinea pig fat (f.a.d.)
Concentration / amount:
Following a 2 week rest period. 0.5% of f.a.d. was applied to intact skin and 0.2% of f.a.d. was applied to abraded skin, respectively.
Day(s)/duration:
1 day
Adequacy of challenge:
not specified
No.:
#3
Route:
intradermal
Vehicle:
other: Test material in propylene glycol
Concentration / amount:
Injections of 0.1ml of a 0.5% solution were injected in the sacral region.
Day(s)/duration:
1 day
Adequacy of challenge:
not specified
No.:
#4
Route:
epicutaneous, open
Vehicle:
other: 1:1 acetone-dioxane containing 13% guinea pig fat (f.a.d.)
Concentration / amount:
Follwing 2 and 3 weeks later 0.5% of f.a.d. soluiton was applied to inact skin and 0.2% of f.a.d. solution was applied to abraded skin, respectively.
Day(s)/duration:
1 day
Adequacy of challenge:
not specified
No. of animals per dose:
10 each
Details on study design:
For sensitization, nine applications to abraded skin were made during a 2 week period with 0.05, 0.1, 0.2 and 0.5% solutions of f.a.d (1, 1, 2 and 6 aplications, respectively). Following a two-week rest period, a challenge test was done which consisted of applying a 0.5% and 0.2% f.a.d. solution of the test material to intact and abraded skin, respectively. In addition, another group of 10 male guinea pigs were tested for skin sensitization by giving each of them intradermal injection of 0.1ml of a 0.5% solution of the test material in propylene glycol in the sacral region; these animals were given challenge tests two and three weeks later by aplying a 0.5% and 0.2% f.a.d. solution of the test matrial to intact and abraded skin, respectively.
Challenge controls:
none
Positive control substance(s):
not specified

Results and discussion

Positive control results:
none

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
2nd reading
Group:
test chemical
Dose level:
0.1ml of a 0.5% f.a.d. solution
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Group:
test chemical
Dose level:
0.1ml of a 0.5% f.a.d. solution
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
1
Clinical observations:
None
Key result
Reading:
1st reading
Group:
positive control
Dose level:
0.1 ml of a 0.5% f.a.d. solution
No. with + reactions:
1
Total no. in group:
1

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Shown to be a strong skin sensitizer