Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Reference substance name:
checked and confirmed
IUPAC Name:
checked and confirmed
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 chemical
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 chemical
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.