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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
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:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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'-tetrone
Details on test material:
- CAS of test material (as cited in study report): 4051-63-2
- Substance type: Solid / red
- Physical state: solid
- Analytical purity: 100 area-% by HPLC-analysis
- Purity test date: 2011
- Lot/batch No.: 0003908072

- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany

- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: average 202g (females) and 237g (males)
- Fasting period before study: none
- Housing: single
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): no data, air-conditioned room used.
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 2011-11-01 To: 2011-11-15

- Fur clipping about 24 hours before administration

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm²
- % coverage: 10%
- Type of wrap if used: semi- occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied: 5g/kg bw
- Concentration (if solution): 40g/100ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 3 g/kg bw
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred.
Mortality:
none
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
No effects
Other findings:
Due to the red discoloration of the application area reading of skin redness could not be determined from study day 1 until study day 3. Thereafter no erythema was noted. No edema was noted during observation period.
Additionally test item residues were noted on study day 6 and persisted in two animals until study day 8.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU

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