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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:
2002-05-21 until 2002-08-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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
Justification for non-LLNA method:
Test was done in 2002, LLNA has not been available at that time.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CAVASOL W6 HP
- Physical state: solid powder
- Analytical purity: 95.9% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 63B001
- Expiration date of the lot/batch: 2003-02-28
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

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 Deutschland, Kisslegg
- Weight at study initiation: 342-389 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Milli-U-Water
Concentration / amount:
Concentrations: 50%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Milli-U-Water
Concentration / amount:
Concentrations: 50%
No. of animals per dose:
10 in main study, 5 in the control
Details on study design:
RANGE FINDING TESTS:
2 Animals were intradermally treated with 2-20% concentration of the test items. No signs of irritation or systemic toxiocity occured. 4 Animals were topically treated with 5 to 50% for 24 and 48 h respectively. No signs of irritation and systemic toxicity were observed.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 7days
- Test groups: pure substance or TS in water
- Control group: water
- Site: shoulder region
- Frequency of applications: days 1, 7 and 8
- Duration: intradermally and dermally 48h occlusive
- Concentrations: 50%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: beginning on day 22 for 3 days
- Exposure period: 24 h
- Test groups: pure substance
- Control group: water
- Site: shoulder region
- Evaluation (hr after challenge): 24, 48, and 72 h

Positive control substance(s):
yes
Remarks:
alpha Hexylcinnamicaldehyde

Results and discussion

Positive control results:
The reliability control worked as expected. The test was prepared separately in March/April 2002 with 20% .alpha.-Hexylcinnamicaldehyde. 1/10 animal showed score 3 reactions, 1 showed score 2 reactions and 3 showed score 1 reactions after 24 h. 5 nimals showed no reaction.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not sensitizing to the skin in a OECD 406 Guinea Pig Maximation Test under the conditions used.
Executive summary:

A guinea pig maximization test on Cavasol W6 HP (test substance) according to OECD 406 did not show any sensitizing effects nor any sign of toxicity or irritation when applied. The controls worked as expected.