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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
Remarks:
according to EU method B.6

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Directive 92/69/EEC
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study was performed in 1995

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
10 %
Adequacy of induction:
other: highest concentration not giving rise to irritation effects in the preliminary test
Route:
other: topical application
Vehicle:
physiological saline
Concentration / amount:
10 %
Adequacy of induction:
other: highest concentration not giving rise to irritation effects in the preliminary test
Challengeopen allclose all
No.:
#1
Route:
other: no information available
Vehicle:
physiological saline
Concentration / amount:
5 %
Adequacy of challenge:
not specified
No.:
#2
Route:
other: no information available
Vehicle:
physiological saline
Concentration / amount:
1 %
Adequacy of challenge:
other: highest concentration not giving rise to irritation effects in the preliminary test
No. of animals per dose:
20 animals treatment group
10 animals control goup

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical signs recorded
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical signs recorded
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical signs recorded
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical signs recorded
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
no signs of sensitization observed