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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:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
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
Details on test material:
- Name of test material (as cited in study report): VP Si 263

- Physical state: colourless, slightly cloudy liquid

- Storage condition of test material: room temperature, dar, protected against moisture

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River laboratories, Kissleg, Germany
- Age at study initiation:
- Weight at study initiation:
- Housing: 2 or 3 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
Induction: undiluted test substance
Challenge: 60% (w/w) dilution in sesame oil
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
Induction: undiluted test substance
Challenge: 60% (w/w) dilution in sesame oil
No. of animals per dose:
Test group: 20
Control group: 10
Pilot experiment: 8
Details on study design:
RANGE FINDING TESTS: Induction and challenge employed DUhring chambers with soaked patches either with 40%, 60% or 80% (w/w) of the test substance diluted in sesame oil or the undiluted test substance (100%).

MAIN STUDY
A. INDUCTION EXPOSURE
24 hours before application the skin on the left flank of the animals had been shorn over an area of approximately 4 cm x 6 cm. A Duhring chamber was filled with a patch of 2 cm x 2 cm size with undiluted test substance and applied to the left flank of each animal of the test group. The chambers were fixed. The animals of the control group were treated similarly, with the exception that they received only the vehicle (sesame oil) instead of the test substance. The dressing was removed after 6 hours, the skin was cleaned with warm water and the reactions observed were classified.

B. CHALLENGE EXPOSURE
The challenge application was carried out on control and test group animals 2 weeks (corresponding to day 28 of the application period) after the last dermal induction. Areas of 4 cm x 6 cm on both flanks of the animals were shorn 24 hours before application. Duhring chambers were filled with patches with the 60% (w/w) dilution of the test substance in sesame oil and were laid on the untreated right flank and fixed. After 6 hours the dressing was removed and the skin was cleaned with warm water. After a further 21 hours after removal of the patches the skin was shorn. Three hours later ( = 24 hours after patch removal) the skin reaction was assessed. The assessment was repeated after a further 24 hours.
Challenge controls:
Challenge controls were included and showed no signs of irritation or sensitisation.
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: 3. Induction
Hours after challenge:
6
Group:
test group
Dose level:
undiluted
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
Induction was conducted 3 consecutive times; by the last induction most of the animals showed signs of irritation.
Remarks on result:
not determinable
Reading:
other: induction
Hours after challenge:
6
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions.
Remarks on result:
not determinable
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
60% (w/w) in sesame oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reactions.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
60% (w/w) in sesame oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on a non-adjuvant sensitisation test in guinea pigs conducted according to an OECD guideline and in compliance with GLP, the test item was found not sensitising to guinea-pig skin in accordance with current regulation (EC) No 1272/2008.
Executive summary:

No unusual findings were observed , and the body weight development of the animals was positive and within normal ranges. In the challenge no visibile changes to the treated skin sites were observed; there was no positive challenege result in all test group animals.