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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Pigment Yellow 93
Specific details on test material used for the study:
- Lot/batch No.:7218
- Expiration date of the lot/batch: 02/ 2023
- Stability under test conditions: stable
- Storage condition of test material: The substance was indicated to be stored in the airtight delivered plastic container in the darkness at room temperature

In vivo test system

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, ReH CZ 21760118
- Age at study initiation: 8 to 10 weeks (at start of dosing)
- Weight at study initiation: 17,3 to 21,6 g (at start of dosing)
- Housing: in groups of maximum six
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

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

IN-LIFE DATES: From: 3.11.2008 To: 5.11.2008

Study design: in vivo (LLNA)

Vehicle:
other: DAE 433 - mixture of40% dimethylacetamide, 30% acetone and 30% ethanol
Concentration:
0.1, 1 and 10%
No. of animals per dose:
6
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: The test item is a pigment and insoluble in organic or inorganic solvents. A suspension of up to 10% could be tested.
- Irritation: Not irritating
- Lymph node proliferation response: No data

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: non-radiolabelled LLNA
- Criteria used to consider a positive response: The results of the LLNA were evaluated according to the following criteria.
The following thresholds were determined by Ulrich (2007) from analysis of historical data:
Ear weight index: 1.05
LN weight: 1.2
LN cell count: 1.3

1. Values which exceed these thresholds were considered positive
- when a statistically significant increase in one of the parameters occurs and a clear
concentration-dependence can be derived
- or with no statistical significance, but a clear concentration-dependence.
2. Values which are below these thresholds were considered positive
- when a statistical significant occurs in one of the parameters together with a clear
concentration dependence.

TREATMENT PREPARATION AND ADMINISTRATION: Before start of application the suspension was mixed for 5 minutes with a magnetic stirrer and then were still mixed during application.
Positive control substance(s):
other: Dinitrochlorobenzene
Statistics:
For statistical calculations the software Statgraphic® Centurion (version XV, USA) was used. At first the global comparison of all three values of the concentration groups with vehicle control was performed by applying the non-parametric Kruskal-Wallis test, and then the non-parametric two-group Mann-Whitney rank test (probability level 0.05) was applied to all two-group comparisons.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
other: LN cell count index
Value:
1
Test group / Remarks:
Negative control
Parameter:
other: LN cell count index
Value:
4.06
Test group / Remarks:
Positive control
Key result
Parameter:
other: LN cell count index
Value:
0.84
Test group / Remarks:
0.1% test substance
Key result
Parameter:
other: LN cell count index
Value:
0.84
Test group / Remarks:
1% test substance
Key result
Parameter:
other: LN cell count index
Value:
1.04
Test group / Remarks:
10% test substance

Any other information on results incl. tables

Mean local lymph node weight (mg)

positive control: 14,87

Negative contro: 5,68

Test substance 0.1% : 5,77

Test substance 1%: 5,68

Test substance 10%: 5,45

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met