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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
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
423-730-5
EC Name:
-
Cas Number:
250688-43-8
Molecular formula:
C18H15N3Na2O9S3
IUPAC Name:
Disodium 4-amino-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-1-sulfonate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: distilled water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 10% w/v in distilled water
Topical: 50% w/w in distilled water
Concentration of test material and vehicle used for each challenge:
50% W/W in distilled water
25% w/w in distilled water
10% w/w in distilled water
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal
Vehicle:
other: distilled water
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 10% w/v in distilled water
Topical: 50% w/w in distilled water
Concentration of test material and vehicle used for each challenge:
50% W/W in distilled water
25% w/w in distilled water
10% w/w in distilled water
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:
50%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not reported
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not reported
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not reported
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not reported
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not reported
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not reported
Remarks on result:
not measured/tested

Any other information on results incl. tables

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

Signs of irritation during induction:

Intradermal:

In both the initial study and the retest, red/orange

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.

In the initial study, very slight erythema was noted at the

vehicle intradermal injection sites of two control group

animals at the 24-hour observation and in one control group

animal at the 48-hour observation. In the retest there was

no evidence of erythema in control animals at either

observation.

Topical:

In both the original study and the retest, red/orange

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. In the

retest, very slight oedema was noted at the induction sites

of six test group animals at the 1-hour observation.

in the initial study, bleeding from the intradermal

injection sites caused by the animal scratching, was noted

at the induction site of one control animal at the 1-hour

observation. A hardened dark brown/black-colouredscab was

noted at this site at the 24-hour observation.

Evidence of sensitisation of each challenge concentration:

The results of the initial study were equivocal and did not

permit classification of the sensitisation potential of the

test material. A retest was performed to confirm the result.

In each test 10 test and 5 control animals were used.

Other observations:

At the 1st challenge, staining of the skin prevented

evaluation of erythema in 5 animals at 50% and 4 animals at

25%. The skin reactions reported are oedema. In the retest

one test group animal showed a lower than expected

bodyweight gain over the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not classified