Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.6 (Meerschweinchen-Maximierungstest (GPMT)); OECD 406
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Hsd Win:DH (SPF)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: a) 5 % (w/v) in physiologischer

NaCl-Lsg.

b) 5 % (w/v) in Freunds Adjuvans mit

physiologischer NaCl-Lsg. 1:1

b) Epidermal: 50 % (w/v) in physiologischer NaCl-Lsg.

"ENGLISH"

a) Intradermal: a) 5 % (w/v) in physiological

NaCl solution

b) 5 % (w/v) in Freund's adjuvant with

physiological NaCl solution 1:1

b) Epidermal: 50 % (w/v) in physiological NaCl solution

Concentration of test material and vehicle used for each challenge:
Provokation: a) 25 %

b) 50 % (w/v) jeweils in physiologischer

NaCl-Lsg.

"ENGLISH"

Challenge: a) 25 %

b) 50 % (w/v) in each case in physiological

NaCl solution
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: a) 5 % (w/v) in physiologischer

NaCl-Lsg.

b) 5 % (w/v) in Freunds Adjuvans mit

physiologischer NaCl-Lsg. 1:1

b) Epidermal: 50 % (w/v) in physiologischer NaCl-Lsg.

"ENGLISH"

a) Intradermal: a) 5 % (w/v) in physiological

NaCl solution

b) 5 % (w/v) in Freund's adjuvant with

physiological NaCl solution 1:1

b) Epidermal: 50 % (w/v) in physiological NaCl solution

Concentration of test material and vehicle used for each challenge:
Provokation: a) 25 %

b) 50 % (w/v) jeweils in physiologischer

NaCl-Lsg.

"ENGLISH"

Challenge: a) 25 %

b) 50 % (w/v) in each case in physiological

NaCl solution
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
Keine; vor der zweiten Induktion wurde die Haut der Tiere
mit Natriumlaurylsulfat vorgereizt.

"ENGLISH"

None; the skin of the animals was pre-irritated with sodium
lauryl sulphate prior to the second induction.

Evidence of sensitisation of each challenge concentration:
Keine

"ENGLISH"

None

Other observations:
Nach der zweiten Induktion bildeten sich am 10. Tag an zwei
Tieren blutende Wunden, die aber nach Krustenbildung bis zum
15. Tag wieder abheilten.

"ENGLISH"

After the second induction bleeding wounds formed in two
animals on the 10th day. However, after scab formation they
healed again by the 15th day.

Applicant's summary and conclusion

Interpretation of results:
other: not classified