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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: See report below
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.