Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

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:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone

EC Number:

216-125-0

EC Name:

Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone

Cas Number:

1503-48-6

Molecular formula:

C20H10N2O4

IUPAC Name:

quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone

Details on test material:

- Analytical purity:97.59%

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 15.9 - 19.3 g
- Housing: all animals in one group were housed in a cage together as a group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 – 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2014-03-19 To: 2014-04-04

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

5, 10 and 25 % (w/w)

No. of animals per dose:

5

Details on study design:

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: standard H-Methylthymidine incorporation
- Criteria used to consider a positive response: SI > 3

TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal surface
of each ear. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (diameter 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

SI = 9.3%
The periodic positive control experiment was performed in October 2013
Positive control substance: α-Hexylcinnamaldehyde; Vehicle: acetone:olive oil (4+1 v/v)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: EC3 = 16.9%

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See table

Any other information on results incl. tables

No adverse effects on body weight was noted.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. Due to the colour of the test item, redness of the ear skin could not be observered.

The measured ear weights of all animals treated were recorded after sacrifice. A statistically significant or biologically relevant increase in ear weights was not observed in any test item treated group in comparison to the vehicle control group.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is a skin sensitizer of moderate potency.