C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD test guideline 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate

EC Number:

414-110-5

EC Name:

C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate

Cas Number:

1379678-96-2

Molecular formula:

UVCB Substance

IUPAC Name:

tetradecan-1-aminium 1-amino-9,10-dioxo-4-[(2,4,6-trimethylphenyl)amino]-9,10-dihydroanthracene-2-sulfonate

Details on test material:

- Description: blue powder
- Expiration date of the batch: 01-Apr-1997
-Stability under storage conditions: stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approximately 12 weeks old
- Weight at study initiation: 2216-2625 g
- Housing: individually, in labelled cages with perforated floors
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter of 4 mm; Hope Farms, Woerden, The Netherlands), approximately 100 g/day
- Water: tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap: moistened Scotchpak-non-woven patch (2 x 3 cm, 3M, St. Paul, U.S.A.) mounted on Micropore tape (3M, St. Paul, U.S.A.)

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the remaining test item removed using a tissue moistened with tap water and subsequently a dry tissue.
- Time after start of exposure: 4 hours after the application of the test item

SCORING SYSTEM: numerical scoring system according to Draize (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable, no effect

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable, no effect

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable, no effect

Irritant / corrosive response data:

After 24 hours, very slight erythema was observed in the treated skin area of all animals, which had resolved at the following observation (48 hours after exposure). Oedema was not seen during the observation period in any of the animals.

Other effects:

One hour after exposure, erythema could not be scored due to blue staining of the treated skin. Although the degree of staining decreased during the course of the study, erythema was difficult to score at the following observations.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

t.