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:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT); OECD 406
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 Crl(HA)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in sesame oil

b) dermal: 25 % in sesame oil

Concentration of test material and vehicle used for each challenge:
dermal 25 % in sesame oil
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal: 5 % in sesame oil

b) dermal: 25 % in sesame oil

Concentration of test material and vehicle used for each challenge:
dermal 25 % in sesame oil
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:
10
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: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 %
No. with + reactions:
10
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: 10.0. 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:
Intradermal injections with Freund's Adjuvant (with and
without test substance) caused well-defined erythema and
edema as well as indurations and encrustations. The
administrations sites treated with the test substance in
sesame oil showed well-defined up to slight erythema and
edema. Intradermal injections of the vehicle alone exhibited
no signs of irritation.


After dermal induction, well-defined edema, indurated and
encrusted skin as well as sproadically open wounds were
observed at the sites previously treated with Freund's
Adjuvant. The administrations sites treated with the test
substance alone showed slight erythema and edema. The
administration sites treated with the vehicle alone showed
no signs of irritation.

Evidence of sensitisation of each challenge concentration:
Test group: 10/10

Controll group: 0/5

Other observations:
The body weight gains of the animals were not impaired. The
treated animals showed no clinical signs of intoxication
throughout the study.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Based on the test result the test substance is classified as Skin Sens cat 1B, H317.