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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Because a guinea pig maximisation test was already available.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-240-8
EC Name:
-
Cas Number:
302933-83-1
Molecular formula:
C55-n H95.5-2n N7 013 Na1.5 (n-0-6) molecular weight: 1097-l4n (n=0-6)
IUPAC Name:
Sodium surfactin
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% DNCB
No. with + reactions:
2
Total no. in group:
2
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% DNCB
No. with + reactions:
2
Total no. in group:
2
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

An induction exposure by intradermal injection of 0.1% Sodium surfactin and by topical application of occlusive patch of 25% Sodium surfactin, followed by a challenge exposure by topical application of occlusive patch of 12.5% and 6.25% sodium surfactin caused no dermal reaction at 24 or 48 hrs. after removing the patch.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It is concluded from the results that sodium surfactin has no skin sensitisation property for guinea pigs.
Executive summary:

An induction exposure by intradermal injection of 0.1% Sodium surfactin and by topical application of occlusive patch of 25% Sodium surfactin, followed by a challenge exposure by topical application of occlusive patch of 12.5% and 6.25% sodium surfactin caused no dermal reaction at 24 or 48 hrs. after removing the patch.

It is concluded from the results that sodium surfactin has no skin sensitisation property for guinea pigs.