Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22.11.1994 to 16.12.1994
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guinea Pig Maximization Test of Magnusson and Kligman
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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:
other: ethanol
Concentration / amount:
25 % in ethanol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
25 % in ethanol
No. of animals per dose:
Group 1: 10 animals, negative control group
Group 2: 20 animals, 0.1 ml of 0.25 % test suspension
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
max 0.6 ml 25 % test compound in ethanol
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: max 0.6 ml 25 % test compound in ethanol. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
max 0.6 ml 25 % test compound in ethanol
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: max 0.6 ml 25 % test compound in ethanol. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.3 ml 25 % test compond in ethanol
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.3 ml 25 % test compond in ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3 ml 25 % test compound in ethanol
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.3 ml 25 % test compound in ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
other: mild sensitization potential (Grade II)
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
According to the classification scheme of Magnusson and Kligman the test compound SND 855 BS Y has to be classified as a substance with a mild sensitization potential (Grade II) based on the 12 % positive reactions registered under the stated study conditions.
According to the German Chemicals Act the compound SND 855 BS Y has not to be classified as a sensitizer and no labelling is necessary.
Executive summary:

According to the classification scheme of Magnusson and Kligman the test compound SND 855 BS Y has to be classified as a substance with a mild sensitization potential (Grade II) based on the 12 % positive reactions registered under the stated study conditions. According to the German Chemicals Act the compound SND 855 BS Y has not to be classified as a sensitizer and no labelling is necessary.