Reaction mass of 6-Chloro-2-{4[ethyl(2-hydroxyethyl)amino]phenyl}-1-methylbenzo[cd]indolium hydroxide and 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Test start date: 15 December, 1990; Test end date: 22 December, 1990; Study completion date: 13 March, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-bromo-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium hydroxide

IUPAC Name:

Reaction mass of 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-bromo-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate and 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium hydroxide

Test material form:

solid

Specific details on test material used for the study:

- Substance identified as: FAT 31064/F
- Batch No.: EN 158496.82 / HEW 133/6
- Description: powder
- Stability of test article: stable; expiration date: November 1994
- Stability of test article dilution: stable for at least 2 hours
- Safety Precautions: Gloves, goggles and face mask were sufficient to assure personnel health and safety.

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

females were used

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Füllinsdorff
- Age at study initiation: 23 weeks
- Weight at study initiation: 3.6 - 3.8 kgs
- Housing: individually in steel cages
- Diet: Pelleted standard Kuba 341, Batches 49/89 and 50/89 rabbit maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: ad libitum
- Acclimation period: 4 days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with temperature 20±3 degrees centigrade, relative humidity 40-70%, 12 hours artificial fluorescent light/12 hours dark, music/light period.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females

Details on study design:

- On test day 1, 0.5 g of the test article was applied to approx. 6 square cm of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours.

Observations:
Viability / Mortality: daily.
Body Weights: Start of acclimatization, Day 1 of test (application day) and at termination of observation.

Symptoms:
Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the OECD numerical scoring system.
The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.
The corrosive properties of the test article and the staining of the treated skin area related to the test article were described and recorded.

Necropsy
The observation was terminated 72 hours after application of the test article.
All rabbits were killed by an intravenous injection of T61 (Hoechst AG) into the ear vein and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

COLORATION: In the area of application, blue staining of the treated skin by pigment or coloring of the test article was observed in all animals from 1 hour to 72 hours after treatment (termination).

BODY WEIGHTS: The body weight gain of all rabbits was similar.

CLINICAL SYMPTOMS / MORTALITY

No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 31064/F was considered to be a "non-irritant" to the skin.

Executive summary:

The irritation potential of FAT 31064/F was evaluated in a study conducted according to OECD Guideline 404.

3 female New Zealand whiate rabbits were used for this study. A gauze patch (20 cm²) bearing 0.5 g of the test substance was applied to the shaved area on flank for 4 hours. The skin reactions were evaluated 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

No erythema or edema was observed at any timepoints. Hence, FAT 31064/F was considered to be a non-irritant to the skin.