Registration Dossier

Diss Factsheets

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
Guideline:
other: Annex V
GLP compliance:
yes

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction: undiluted as supplied



Topical induction: undiluted as supplied

Concentration of test material and vehicle used for each challenge:
Topical challenge: 100 and 50% w/v in liquid paraffin
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal induction: undiluted as supplied



Topical induction: undiluted as supplied

Concentration of test material and vehicle used for each challenge:
Topical challenge: 100 and 50% w/v in liquid paraffin
No. of animals per dose:
Number of animals in test group: 11
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 chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
11
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: 11.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
11
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: 11.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
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: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
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:
100 %
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: 100 %. 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: 100 %

Signs of irritation during induction:
Skin Reactions Observed After Intradermal Induction

Slight erythema was noted at the intradermal induction sites
of the preliminary sighting test animals following
treatment with the test material at the concentration of
100% in two animals and at the concentration of 50% in one
animal. No skin reactions were noted at the intradermal
induction sites of the preliminary sighting test animals
following treatment with the test material at the
concentrations of 25%, 12.5%, 6.25% and 3.125%.

The concentration chosen for use in the Intradermal
Induction phase of the main test was 100% (maximal non
necrotising concentration (MNNC)).


Skin Reactions Observed After Topical Induction

No skin reactions were noted at the topical induction sites
of the preliminary sighting test animals following treatment
with the test material at concentrations of 100%, 50%, 25%
and 12.5%.

The concentration chosen for use in the 2nd topical
Induction of the main test was 100% and the 1st
concentration chosen for the MNIC (maximal non irritant
concentration) determination was 100%.

Evidence of sensitisation of each challenge concentration:
Skin Reactions Observed After Topical Challenge

100%

No skin reactions were noted at the topical challenge site
of the test or control group animals at the 24 and 48-hour
observations.

50% in liquid paraffin

No skin reactions were noted at the topical challenge site
of the test or control group animals at the 24 and 48-hour
observations.

Other observations:
Bodyweight gains were comparable to the control group.

Applicant's summary and conclusion

Interpretation of results:
other: not classified