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: OECD Guideline No.406 EC Directive 92/69/EEC Annex V Test B.6 OPPTS 870.2600
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Guinea pigs Dunkin-Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:Topical application: Wk 1=50%, Wk 2=25%, Wk 3=10%Due to adverse reactions, the concentration was reduced eachweek.Maize oil was used as the vehicle.Concentration of test material and vehicle used for each challenge:Concentration: 10%Maize oil was used as the vehicle.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:Topical application: Wk 1=50%, Wk 2=25%, Wk 3=10%Due to adverse reactions, the concentration was reduced eachweek.Maize oil was used as the vehicle.Concentration of test material and vehicle used for each challenge:Concentration: 10%Maize oil was used as the vehicle.
No. of animals per dose:
Number of animals in test group: 20Number 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:
10 %
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 14.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
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: 10 %. 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: 10 %

Signs of irritation during induction:
At 50% SNEA, discrete to moderate erythema was noted and 7
animals had hard skin or scabbing at the test site.  In week
2 (25% SNEA), discrete to moderate erythema and scabbing,
dry, flaky or hard skin was noted.  At week 3 (10% SNEA),
discrete to moderate erythema was noted.

Evidence of sensitisation of each challenge concentration:
Positive responses were noted in the majority of test group
animals.  Reactions were either discrete or patchy erythema
(1) or moderate and confluent erythema (2).  No positive
responses were observed in control group animals.

Other observations:
Dose Ranging for Induction and Challenge:  Ca. 24h after a
topical application of 2000 mg/kg, the animals were humanely
killed.  The animals were found lying on their sides at
morning check.  They could not move around nor stand, were
cold to touch and breathing was laboured.  Aminals were
constantly trying to stand up.  Bodyweights had decreased.
At the 1000 mg/kg dose level (topical), the animals
demonstrated laboured breathing, locomotion difficulties and
were cold to touch 24 h after application.  Based on these
reactions, the Buehler Test method was used.


Main Study:  In the second induction, dark extremities and
head tremors were observed.

Applicant's summary and conclusion

Interpretation of results:
other: irritant