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 (Maximisation)
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Guinea Pig (Dunkin-Hartley)

Study design: in vivo (non-LLNA)

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

1% (w/v) in arachis oil B.P.


b)Topical Induction:

25% (w/v) in arachis oil B.P.

Concentration of test material and vehicle used for each challenge:
10% (w/w) in arachis oil B.P.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a)Intradermal Induction:

1% (w/v) in arachis oil B.P.


b)Topical Induction:

25% (w/v) in arachis oil B.P.

Concentration of test material and vehicle used for each challenge:
10% (w/w) in arachis oil B.P.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20 %
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
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

Signs of irritation during induction:
Scattered mild redness or moderate and diffuse redness was
elicited by the test material at sixteen treatment sites one
hour after patch removal and continued to be noted at all
treatment sites at the 24-hour observation. Other adverse
reactions noted were bleeding, due to fissuring and/or open
wounds and scattered scabbing.


No adverse reactions were noted in the control group
animals.

Evidence of sensitisation of each challenge concentration:
6 out of 20

Other observations:
Desquamation was noted at 48 & 72 h in some animals , in one
animal evaluation of erythema was not possible due to the
degree of desquamation.


Bodyweight gains of animals in the test group, between day 0
and day 25, were comparable to those observed in the
control group animals over the same period.

Applicant's summary and conclusion

Interpretation of results:
other: irritant