Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guidleine study performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas

In vivo test system

Test animals

Species:
guinea pig
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
The test substance ws diluted to 2.5 (wlw) with physiological saline,
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
The test substance ws diluted to 2.5 (wlw) with physiological saline,
No. of animals per dose:
Experimental group: 20 females
Control group : 10 females
Details on study design:
The intradermal route of administration (first induction) was selected in order to obtain optimal contact between POLYCAT 9 and elements of the immunosystem. Freunds Complete Adjuvant (FCA) was added to attract circulating immunocompetent cells to the injected area.
The dermal route of administration (second induction and challenge) was 5 selected because POLYCAT 9 may accidentally come into contact with the skin during manufacture, handling and use.
Challenge controls:
The test and control guinea pigs were challenged two weeks after the epidermal induction application.
Hair was clipped and shaved from a 5 x 5 cm area on the left flank of each guinea pig. A volume of 0.05 ml of each of the following three test substance concentrations and the vehicle were applied using Square chambers attached to Micropore tape:
a = 5 % (wlw) in distilled water.
b = 2 % (wlw) in distilled water.
c = 1 % (wlw) in distilled water.
d = distilled water.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study..

Any other information on results incl. tables

Twelve animals showed a skin reaction in response to the 5% test substance concentration. These reactions were characterised by red spots and scaliness.

None of the animals showed a skin reaction in response the 2% and 1% concentrations.

Taking into account the intensity of the responses and comparing these with the reactions seen in the control animals, no animals showed a positive skin reaction in response to the 5 % concentration.

No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.

These results lead to a sensitisation rate of 0 per cent, which indicates that POLYCAT 9 has weak sensitizing properties in this test applying the rating of allergenicity described by Kligman A.M. (1966).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the cnditions used in this study, Polycat 9 induced no sensitization. The epidermal exposure to Polycat 9 in the induction phase resulted in severe skin irritation.