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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb to Mar 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
- modified maximization test: an epidermal induction on the scarified skin is performed instead of intracutaneous induction
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: liquid parrafin
Concentration / amount:
intradermal induction: see "Any other information on materials and methods"
topical induction (days 1, 2 and 3): 25 %
topical challenge (days 21 and 28): 25 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: liquid parrafin
Concentration / amount:
intradermal induction: see "Any other information on materials and methods"
topical induction (days 1, 2 and 3): 25 %
topical challenge (days 21 and 28): 25 %
No. of animals per dose:
control group: 10 (5/sex)
test substance group: 10 (5/sex)
pre-test (local tolerance test, rechallenge control group): 6 (3/sex)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
challenge 25 %
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
very slight to slight reddenings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: very slight to slight reddenings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
challenge 25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
challenge 25 %
No. with + reactions:
2
Total no. in group:
9
Clinical observations:
very slight to slight reddenings
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 2.0. Total no. in groups: 9.0. Clinical observations: very slight to slight reddenings.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
challenge 25 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 25 %. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
very slight to slight reddenings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: very slight to slight reddenings.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
No. with + reactions:
3
Total no. in group:
6
Clinical observations:
very slight to slight reddenings
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight to slight reddenings.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none.

Any other information on results incl. tables

One female animal of the test group was found dead on day 2. The animal had possibly died from stress (due to the bandage) during the first induction.

After the first challenge and the rechallenge 1 or 2 of a total of 9 animals showed very slight to slight reddenings on the treated area only 24 hours after the end of challenge. Very slight to slight reddenings each occurred in 3 control animals (first challenge 3/10, rechallenge 3/6).

Applicant's summary and conclusion

Executive summary:

In a modified guinea pig maximization test (GPMT) according to OECD TG 406 no skin sensitizing potential of the test substance could be observed based on the results after the first challenge and the rechallenge with 25 % ZK 9340.