Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry, permission to refer granted by ECHA

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Magnusson's Maximization test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
2.75% and 5.5% in water (intradermal injection)
Concentration of test material and vehicle used for each challenge:
5.5% in water (patch application)
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
2.75% and 5.5% in water (intradermal injection)
Concentration of test material and vehicle used for each challenge:
5.5% in water (patch application)
No. of animals per dose:
Number of animals in test group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5.5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 5.5 % Evidence of sensitisation of each challenge concentration: No positive reactions. Other observations: In the preliminary test the concentration of 5.5% appears non irritant for both topical and intradermal routes.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Maximum concentration not causing irritating effects in preliminary test: 5.5 %
Evidence of sensitisation of each challenge concentration: No positive reactions.
Other observations: In the preliminary test the concentration of 5.5% appears non irritant for both topical and intradermal routes.