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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-07-11 to 2003-10-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted 24 April 2002
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 17.6 - 25.0 g
- Housing: groups of 4
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

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

IN-LIFE DATES: From: day 1 To: day 5

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
pre-test for irritation: 1, 2.5, 5 and 10 % (w/v)
main test: 2.5, 5 and 10 % (w/v)
No. of animals per dose:
pre test: 2
main test: 4 (f) per group (3 test groups, 1 control group) total 16 (f)
Details on study design:
RANGE FINDING TESTS:
In a non-GLP conform pre-test in two mice, test item concentrations of 1 %, 2.5 %, 5 % and 10 % (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application. 10 % (w/v) was the highest technically achievable concentration in the chosen vehicle.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD TG 429
- Criteria used to consider a positive response: A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
- Topical application of 25 µL test item preparation (test group) or vehicle (control group)
- five days after topical application: iv application of 3H-methyl thymidine
- five hours after treatment with 3H-methyl thymidine, necropsy and analysis of the 3H thymidine incorporation in draining lymph nodes
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Dunnets Test

Results and discussion

Positive control results:
Conc. SI
2.5 %: 2.0
5 % 2.3
10 % 2.0

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
Test Group 2.5 %
Key result
Parameter:
SI
Value:
2.3
Test group / Remarks:
Test Group: 5 %
Key result
Parameter:
SI
Value:
2
Test group / Remarks:
Test Group: 10 %

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not a skin sensitiser under the described conditions in this assay.
Executive summary:

In this GLP-compliant LLNA study according to OECD 429, the test material was found to be not a skin sensitiser up to the highest technically achievable concentraion of 10 % in the selected vehicle.