14H-anthra[2,1,9-mna]thioxanthen-14-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study; Standard and non Standard test method, poor reporting and characterisation of test sample

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Test guideline 1

Qualifier:

no guideline followed

Deviations:

not applicable

Remarks:

Barail Test using injection

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

5 animals employed

Principles of method if other than guideline:

Skin was shaved at the flanks of rabbits. 0.2 ml of a solution of the test material in sesame oil were injected intracutaneously at concentrations of 10, 5, 1, 0.1, 0.01, and 0.001 %. The pure vehicle served as a control.
In a second part of the study 0.5 ml of the highest concentrations (5 & 10 %) were applied epidermally on the intact skin and evaluated visually. This treatment was repeated on 5 consecutive days.

GLP compliance:

no

Remarks:

pre-dates GLP regulations

Test material

Test material information

Constituent 1

Reference substance name:

Fluoreszenzrot GG

IUPAC Name:

Fluoreszenzrot GG

Test animals

Species:

rabbit

Strain:

other: Yellow-Silver

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individual cages
- Diet (e.g. ad libitum): Altromin ad lib.
- Water (e.g. ad libitum): no data
- Acclimation period: no dat

ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:

other: Part 1: injection; Part 2: open

Preparation of test site:

shaved

Vehicle:

other: sesame oil

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): 0 - 0.001- 0.01 -0.1- 1- 5-10 %

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 ml

Duration of treatment / exposure:

no data

Observation period:

no data

Number of animals:

5

Results and discussion

In vivo

Results

Irritation parameter:

other: visual inspection and expert judgment

Basis:

mean

Time point:

other: no data

Score:

0

Max. score:

0

Remarks on result:

other: No scores were reported

Irritant / corrosive response data:

Injection of 5 and 10 % induced erythema of the skin. Epidermal treatment caused no effects.

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test material did no cause adverse reactions after epidermal application to the intact shaved skin of 5 rabbits.

Executive summary:

Five daily epidermal applications of 5 and 10 % solutions of the test material in sesame oil to the shaved skin of rabbits caused no adverse reactions.

Intradermal injection of the test material into the shaved skin of rabbits at 0.001 to 10 % in sesame oil caused only mild reactions at 5% and higher.

The test material is considered non irritant after topical application.