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Diss Factsheets

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:
key study
Study period:
February to September 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.

Test material

Constituent 1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Information removed from report
- Age at study initiation: 5-8 weeks
- Weight at study initiation: 300-500 g
- Housing: Suspended metal cages with mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 24-56
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Alembicol D
Concentration / amount:
Induction intradermal- 0.5% (highest concentration to cause irritation without adverse effect on animals)
Induction topical - 25% (highest concentration to cause irritation without adverse effect on animals)
Topical challenge - 10 and 5% (based on 10% being the highest non-irritant concentration)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
Induction intradermal- 0.5% (highest concentration to cause irritation without adverse effect on animals)
Induction topical - 25% (highest concentration to cause irritation without adverse effect on animals)
Topical challenge - 10 and 5% (based on 10% being the highest non-irritant concentration)
No. of animals per dose:
20 test, 10 control, 5 positive
Details on study design:
Induction: On Day 1 three pairs of intradermal injections were administered to test animals. One week after the injections, an occlusive application of the test material was applied on the skin of the test animals, left for 48 hours. Control animals received analogous treatment without test material.
Observations on skin reactions occurred after ca. 24 hours following intradermal induction and following the removal of the dressings for the topical induction.

Challenge: Control and test animals were challenged topically two weeks after topical induction. The patches were sealed and left for 24 hours. A second challenge was conducted 8 days after the first challenge application.


Positive control substance(s):
yes
Remarks:
HCA

Results and discussion

Positive control results:
Well defined irritation was seen in all animals receiving intradermal injections of HCA, at induction. Slight erythema was observed in positive control animals following topical application, at induction. The incidence index of sensitization for the positive control material was 1.0. The severity indices for the positive control animals at 24/48 hours were 2.6/3.0 for the anterior site and 2.6/1.8 for the middle site.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
None
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
3
Total no. in group:
5
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
4
Total no. in group:
5
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
5
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
5
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

No signs of ill health or toxicity were recorded.

Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight to well-defined irritation was seen in test animals at sites receiving the test material.

Topical application: Slight erythema was observed in test animals, no erythema were seen in control animals.

First challenge: Slight to well-defined dermal reactions were observed for the majority of test and control animals at the 24, 48 and 72 hour readings. As it was unclear if the reactions represented sensitization, a second challenge was conducted to confirm reproducibility. The incidence index of sensitization for test substance was 0.95 for the anterior site (10%) and 0.8 for the middle site (5%). The severity indices for the test animals at 24/48 hours were 1.2/1.6 for the anterior site and 1.2/1.4 for the middle site. The severity indices for the control animals at 24/48 hours were 0.6/0.3 for the anterior site and 1.2/0.9 for the middle site.

Second challenge: Dermal reactions were observed for eleven test animals at both the 48 and 72 hour reading compared to none in the controls. Dermal reactions were observed for five test animals following the 72 hour score only, however due to the unusually late onset of these reactions they were considered as inconclusive responses. No reactions were observed for the remaining four test animals. The incidence index of sensitization of the test substance at second challenge was 0.55 at the posterior site (5%) and 0.1 at the middle site (1%).The severity indices for the test animals at 24/48 hours were 0/0.95 for the anterior site and 0/0.1 for the middle site. The severity indices for the control animals at 24/48 hours was 0 for both sites.

The dermal reactions noted for all 5 positive control animals were generally more marked and persistent than those seen for controls. The severity index for the control animals at 24/48 hours were 1.2/1.0 for the anterior site and 0.4/0.6 for the middle site.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
In a Guinea Pig Maximisation skin sensitisation test, conducted according to OECD Test Guidleine 406 and in compliance with GLP, the test material was concluded to cause skin sensitisation. This was based on a positive response in eleven of the twenty test animals at re-challenge. Four animals gave negative responses and the remaining five animals gave inconclusive responses.