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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
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 %
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)
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.

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).

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a guinea pig maximization test (GPMT) according to OECD TG 406 the test substance revealed an ambiguous result after an intradermal induction concentration of 1.25 % ZK 9340 followed by a topical induction concentration of 25 % (Schöbel, 1996a). Based on this study it is not possible to come to any clear conclusion as to whether ZK 9340 possesses a sensitizing effect in the guinea-pig.

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 (Schöbel, 1996b). In this test the animals were topically induced with a concentration of 25 % test substance.

Therefore, regarding the results of the previous study (Schöbel, 1996a) and the present study (Schöbel, 1996b) ZK 9340 was proved to have no sensitizing effect in the guinea-pig using the maximization test as weil as the modified maximization test with higher concentrations for induction.


Migrated from Short description of key information:
Guinea pig maximation test: not sensitising [Schöbel 1996b]

Justification for selection of skin sensitisation endpoint:
First GPMT (Schöbel, 1996a) revealed an ambiguous result since intradermal induction concentration of 1.25 % was to low.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.