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Diss Factsheets

Administrative data

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:
key study
Study period:
1991-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guidleine study performed under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was already existing at the moment of the registration. Therefore we do not conduct a LLNA study because animal welfare reasons.
Species:
guinea pig
Sex:
female
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
The test substance ws diluted to 2.5 (wlw) with physiological saline,
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
Key result
Reading:
1st reading
Group:
positive control
Dose level:
0.1%
No. with + reactions:
8
Total no. in group:
20
Key result
Reading:
1st reading
Group:
positive control
Dose level:
0.5%
No. with + reactions:
12
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
positive control
Dose level:
0.5%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: positve control formaldheyde with 0.5% concentration
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 - 50 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 - 50%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 - 50%
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..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 - 50%
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..

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).

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The substance induced no sensitization in A GPMT. The substance is corrosive.

Justification for selection of skin sensitisation endpoint:
Under the conditions used in this study, the substance induced no sensitization. The epidermal exposure to the substance in the induction phase resulted in severe skin irritation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Not sensitizing in a Guinea Pig Maximisation Test.