[4-[4-(diethylamino)benzhydrylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium hydrogen sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

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:

Similar substance 03

IUPAC Name:

Similar substance 03

Test animals

Species:

other: rat and guinea pig

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALSRATS- 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 gAll 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 vitro

Results

Irritation / corrosion parameter:

other: in vivo test

Value:

> 0

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

> 0

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 the tested substance 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:

other: not irritating

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 the tested substance 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.