Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT))
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: gpg, HsdPoc:DH

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 1 % in Tylose

b) Dermal: 25 % in Tylose

Concentration of test material and vehicle used for each challenge:
Dermal: 25 % in Tylose
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 1 % in Tylose

b) Dermal: 25 % in Tylose

Concentration of test material and vehicle used for each challenge:
Dermal: 25 % in Tylose
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:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
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: 25 %. 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: 25 %

Signs of irritation during induction:
Die intradermalen Injektionen mit FCA (mit und ohne
Testsubstanz verursachten starke Erytheme und Ödeme, sowie
Verhärtungen und Verkrustungen. Die mit der Testsubstanz im
Vehikel verabreichten Injektionen führten zu leichten
Erythemen und Ödemen. Die Injektionen mit dem Vehikel allein
verursachten keine Reizeffekte.

Die mit FCA behandelten Hautstellen zeigten nach der
dermalen Behandlung klar ausgebildete Erytheme und Ödeme,
sowie Verhärtungen und Verkrustungen und sporadisch
Nekrosen. Die dermale Behandlung mit der Testsubstanz im
Vehikel führte zu leichten Erythemen. Die dermale
Verabreichung des Vehikels allein ergab keine Reizeffekte.

"ENGLISH"

The intradermal injections with FCA (with and without test
substance) caused erythemas and oedemas as well as
indurations and incrustations. The injections administered
with the test substance in the vehicle resulted in slight
erythemas and oedemas. The injections with the vehicle alone
did not induce any irritant effects.

The parts of the skin treated with FCA exhibited clearly
defined erythemas and oedemas as well as indurations and
incrustations and sporadic necroses after the dermal
treatment. The dermal treatment with the test substance in
the vehicle resulted in slight erythemas. The dermal
administration of the vehicle alone did not produce any
irritant effects.

Evidence of sensitisation of each challenge concentration:
Behandlungsgruppe: 0/10

Kontrollgruppe:    0/5

"ENGLISH"

Treatment group: 0/10

Control group:   0/5

Applicant's summary and conclusion

Interpretation of results:
other: not classified