Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-04-09 to 2008-09-04
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %; UVCB substance)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Hungarian Supplier:
WOBE Kereskedelmi Kft.
H-1164, Budapest, Garmada u. 10.
- Age at study initiation: Young adult, 10-11 weeks old, age-matched within one week
- Weight at study initiation: The weight variation in animals involved in the study did not exceed  20 % of the mean weight.
- Housing: Individual caging
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, as for human consumption from 500 ml bottle ad libitum
- Acclimation period: 28 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
An irritation/toxicity screen was performed in groups of 2 CBA/Ca mice with test item concentrations of 25 % and 10 % in DMF. This preliminary study was conducted in a similar experimental manner to the exposure phase of the main study. The test item concentrations in the main study ranged from 25-5 %.
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 25 %
- Irritation:
- Lymph node proliferation response:


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:


TREATMENT PREPARATION AND ADMINISTRATION:
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The positive control substance a-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The stimulation index values were 14.9, 15.7 and 9.4 at concentrations of 25 %, 10 % and 5 %, respectively. The stimulation index values were compatible with the conventional biological dose-response.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: F 46 Black (25 % in DMF): 14709.9 (per group) F 46 Black (10 % in DMF): 15498.8 (per group) F 46 Black (5 % in DMF): 9296.2 (per group)

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the present assay F 46 Black, dissolved in an appropriate solvent up to the maximum feasible concentration (25 %), revealed sensitisation potential (sensitiser) in the local lymph node assay.
Executive summary:

Based on a local lymph node assay according to EU method B.42 and OECD guideline 429 the test item F 46 Black revealed sensitisation properties.