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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aggregate state at room temperature: solid
Colour: Yellowish-Red
Stability in solvent: > 24 hrs in OMSO at room temperature
Storage: At room temperature
Expiry date: August 17,2009

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, NL - 5960 AD Horst
- Age at study initiation: 8 - 12 weeks (beginning of acclimatization)
- Weight at study initiation: mean 18.5g
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2004-11-03 To: 2004-11-09

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
7.5, 15 and 30%
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: The data showed that the highest test item concentration, which can be used was a 30 % suspension in acetone:olive oil, 4:1 (viv). In DMF or DMSO only up to 20 % could be suspended
- Irritation: In a non-GLP conform pre-test in !wo mice, test item concentrations of 5, 10, 20, and 30 % (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application. (Due to the intense red colour of the test item local irritation reactions such as ear redness could not be detected" No swelling of the ears was observed.)
- Lymph node proliferation response: not measured in the range-finder

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation
- Criteria used to consider a positive response: 3fold increase in Stimulation index compared to vehicle control

TREATMENT PREPARATION AND ADMINISTRATION: Substance was suspended in vehicle on the day of treatment.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Included for body weight and SI

Results and discussion

Positive control results:
performed in April 2004, a-Hexylcinnamaldehyde in Acetone/olive oil. EC3 = 6.3%

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 7.5% = 0.8 15% = 0.7 30% = 0.5
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: DPM per lymph node: Control: 521 7.5% = 424 15% = 348 30% = 259

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU