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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:
supporting study
Study period:
2004-01-12 to 2004-02-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no reliability check reported
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler 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

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan GmbH, Borchen, GERMANY
- Age at study initiation: not stated
- Weight at study initiation: 300-500g
- Housing: in groups in Terluran cages
- Diet: standard diet: ad libitum
- Water: drinking water ad libitum
- Acclimation period: described as adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/-10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12h/ 12h

IN-LIFE DATES: From: To: not stated but within the period 2004-01-12 to 2004-02-13

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% for induction and challenge
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% for induction and challenge
No. of animals per dose:
20 test, 10 controls
Details on study design:
RANGE FINDING TESTS: 50% (in corn oil) and 100% tested on 2 animals for irritancy

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: left flank
- Frequency of applications: 3 applications at weekly intervals
- Duration: exposure duration 6h
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the final induction
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48h

Challenge controls:
Negative but no concurrent positive control or reliability data provided. A reliability check was to be conducted in the future (BSL 040619).
Positive control substance(s):
no
Remarks:
reliability check was to be conducted in the future (BSL 040619)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
no treatment
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
no treatment
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
other: not included
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: not included

Any other information on results incl. tables

No response was recorded at any time point in the test or control groups.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A well conducted, well reported Buehler sensitization test reported that a 100% concentration of the test material failed to induce a sensitization response in guinea pigs when challenged with the same neat test material. Appropriate concurrent negative controls were included, but the positive compliance test was to be undertaken at a later date.