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Toxicological information

Skin sensitisation

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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: Directive 96/54/EC, B.6. Guinea Pig Maximisation Test, modified according to Maurer and Hess.
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Guinea pigs, Dunkin Hartley, HsdPoc:DH.

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Two epicutaneous induction: 50 % test substance in white
petrolatum - this concentration is the highest technically
feasible test substance concentration.

Additionally: intradermal injections of Freund's complete
adjuvant together with the first epicutaneous induction.

Concentration of test material and vehicle used for each challenge:
Epicutaneous challenge: 50% test substance in white
petrolatum.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Two epicutaneous induction: 50 % test substance in white
petrolatum - this concentration is the highest technically
feasible test substance concentration.

Additionally: intradermal injections of Freund's complete
adjuvant together with the first epicutaneous induction.

Concentration of test material and vehicle used for each challenge:
Epicutaneous challenge: 50% test substance in white
petrolatum.
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 chemical
Dose level:
50 %
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: 50 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
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: 50 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
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:
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: 50 %

Signs of irritation during induction:
Severe erythema and oedema were observed at the induction
site.

Evidence of sensitisation of each challenge concentration:
Test substance group: 10/10 animals (100 %) had very slight
to severe erythema and/or oedema 24 and 48 hours after   the
end of the challenge exposure, attended by eschars in
3/10 animals.

Negative control group: No positive skin reaction in any
animal at any reading time.

Other observations:
No relevant toxic signs other than local effects were
observed.

Applicant's summary and conclusion

Interpretation of results:
other: irritant