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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
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
92/69/EEC, B6 (Maximisation test)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not reported

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-870-1
EC Name:
-
Cas Number:
27624-67-5
Molecular formula:
C14H16N4O9S3
IUPAC Name:
2,4-diamino-5-(2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonic acid
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
albino
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
not specified
Remarks:
distilled water
Concentration / amount:
Intradermal: 10% w/v in distilled water
Topical: 75% w/w in distilled water
Day(s)/duration:
2
Adequacy of induction:
not specified
Challengeopen allclose all
No.:
#1
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water
Concentration / amount:
75% w/w in distilled water
50% w/w in distilled water
Day(s)/duration:
2
Adequacy of challenge:
not specified
No.:
#2
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water
Concentration / amount:
50% w/w in distilled water.
25% w/w in distilled water.
Day(s)/duration:
2
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other:
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
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: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: not performed
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other: not performed
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other:
Remarks:
not performed
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other:
Remarks:
not performed
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other:
Remarks:
not performed
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
other:
Remarks:
not performed

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 75 %

Signs of irritation during induction:

Intradermal:

Orange-coloured staining was noted at the test material

intradermal injection sites of all test group animals at the

24 and 48-hour observations. The staining precluded

evaluation of the degree of erythema.

Very slight erythema was noted at the vehicle intradermal

injection sites of two control group animals at the 24-hour

observation. No skin reactions were noted at the vehicle

intradermal injection sites of control group animals at the

48-hour observation.

Topical:

Orange-coloured staining was noted at the topical induction

sites of all test group animals at the 1 and 24-hour

observations, preventing evaluation of the degree of

erythema.

No skin reactions were noted at the treatment sites of

control group animals at the 1 and 24-hour observations.

Evidence of sensitisation of each challenge concentration:

Skin reactions observed in test group animals at challenge

and rechallenge were attibuted to non-specific skin

irritation, not sensitisation.

Other observations:

Desquamation was noted in some test and control animals

after challenge and rechallenge.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met