4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and OECD testing guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone

EC Number:

223-754-4

EC Name:

4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone

Cas Number:

4051-63-2

Molecular formula:

C28H16N2O4

IUPAC Name:

4,4'-diamino-1,1'-bianthracene]-9,9',10,10'-tetraone

Details on test material:

- Name of test material (as cited in study report): CAS name:[l,1'-Bianthracene]-9,9',10, 10'-tetrone, 4,4'-diamino
- Substance type: red powder
- Physical state: solid
- Analytical purity: 99,5%
- Impurities (identity and concentrations): water (ca 0.5%)
- Purity test date: no data
- Lot/batch No.: E 804112008
- Expiration date of the lot/batch: December 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: 17.1 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°C
- Humidity (%): 30 - 70 %,
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

IN-LIFE DATES: From: 23.2.2009 To: 25.2.2009

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:

six

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

Results and discussion

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

negative control

Results 2

Key result

Parameter:

SI

Value:

1.09

Test group / Remarks:

0.1% test substance

Results 3

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

1% test substance

Results 4

Key result

Parameter:

SI

Value:

1.15

Test group / Remarks:

10% test substance

Results 5

Key result

Parameter:

SI

Value:

3.21

Test group / Remarks:

positive control

Any other information on results incl. tables

No animal died during the main experiment.

No symptoms of toxicity were observed in animals fram the negative contral group and in groups administered by the test substance at the concentration 0.1 %, 1% and 10%. All animals in the positive contral group showed these symptoms: hyperaemia of skin and

clonospasm.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a GLP-compliant study according to OECD TG 429, the substance did not induce any skin sensitization up to the maximum testable concentration (in suspension) of 10%.