Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT))
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: gpg, Himalayan (SPF)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermale Injektion: 0.2 % (w/w) in 1 % wässr.

Carboxymethylcellulose

topische Behandlung: 50 % in 1 % wässrige CMC

Concentration of test material and vehicle used for each challenge:
50 % (w/w) in 1 % wässr. Carboxymethylcellulose
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermale Injektion: 0.2 % (w/w) in 1 % wässr.

Carboxymethylcellulose

topische Behandlung: 50 % in 1 % wässrige CMC

Concentration of test material and vehicle used for each challenge:
50 % (w/w) in 1 % wässr. Carboxymethylcellulose
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
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: 50 %. 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: 50 %

Signs of irritation during induction:
Keine Effekte beobachtet

"ENGLISH"

No effects were observed.

Evidence of sensitisation of each challenge concentration:
Keine

"ENGLISH"

None

Other observations:
Keine

"ENGLISH"

None

Applicant's summary and conclusion

Interpretation of results:
other: not classified