[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP, aged study, poor detail on test conditions Read across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Toxicological studies on malachite green: A triphenylmethane dye

Author:

Clemmensen S., Jensen C., Jensen N., Meyer O., Olsen P., Wurtzen G.

Year:

1984

Bibliographic source:

Arch Toxico l1984) 56: 43-45

Materials and methods

Principles of method if other than guideline:

For skin application a site of 35 cm^2 was clipped 3 h before administration and the site covered by four-ply gauze and an elastic bandage.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Malachite Green Oxalate

IUPAC Name:

Malachite Green Oxalate

Details on test material:

- Malachite Green Oxalate
- Name of test material: Malachite Green Oxalate
- Source: Dansk Orredforder A/S, Brande, Danmark
- Structure: (C23H25N)2 (COO)2 X 2 (COOH)2
- Analytical purity: > 90% detected by TLC

Test animals

Species:

other: rat and guinea pig

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
RATS
- Strain: Wistar rats, Mol: WIST (SPF)
- Weight at study initiation: 170-250 g
- Source: from Molllegard Breeding Centre (L1. Skensved, Denmark)

GUINEA PIG
- Strain: Ssc, AL
- Source: Statens Serumininstitut, (Copenhagen, Denmark)
- Weight at study initiation: 300 g

All were given food and water freely except 16 h before gavage.
For rats
- Temperature: kept at 22 ± 1°C
- Humidity: 60 ± 10%
- Light: from 21.00 to 09.00 with air changes eight times/h.

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Vehicle: aqueous solution
- Concentration: MGH at 20%

Duration of treatment / exposure:

single dose application

Observation period:

1, 2, 3, and 5 h after dosing and each day for 14 days

Number of animals:

Groups of five animals of either sex

Details on study design:

For skin application a site of 35 cm^2 was clipped 3 h before administration and the site covered by four-ply gauze and an elastic bandage (Acrylastic, Beiersdorf AG, FRG)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: See report below

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: See comments

Any other information on results incl. tables

No signs of systemic toxicity were observed after occlusive dermal application of 2000 mg/kg. As a 20% suspension of Malachite Green did not produce visible erythema or oedema on either rats or guinea pigs; authors hadn't deemed it meaningful doing a rabbit skin irritation study. Similarly, within the conditions of the guinea pig maximisation test no effects could be seen on controls or treated animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No signs of systemic toxicity were observed: not visible erythema or oedema on either rats or guinea pigs were observed.

Executive summary:

Rats ang guinea pig were tested for dermal acute toxicity. For skin application a site of 35 cm^2 was clipped 3 h before administration and the site covered by four-ply gauze and an elastic bandage.

No signs of systemic toxicity were observed after occlusive dermal application of 2000 mg/kg. As a 20% suspension of Malachite Green did not produce visible erythema or oedema on either rats or guinea pigs; authors hadn't deemed it meaningful doing a rabbit skin irritation study. Similarly, within the conditions of the guinea pig maximisation test no effects could be seen on controls or treated animals.