Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The experiment is scientifically acceptable, nevertheless details about test method and procedures are missing.

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 Toxicol (1984) 56:43-45

Materials and methods

Principles of method if other than guideline:

Rats were tested for dermal acute toxicity; for skin application a site of 35 cm2 was clipped 3 hours before administration and the site covered by four-ply gauze and an elastic bandage. Test item was administered as 20 % suspension.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

EC Number:

241-922-5

EC Name:

Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate

Cas Number:

18015-76-4

Molecular formula:

C23H25N2 x C2HO4

IUPAC Name:

4-{[4-(dimethylamino)phenyl](phenyl)methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium hydrogen oxalate

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Details on test animals or test system and environmental conditions:

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

ENVIRONMENTAL CONDITIONS
- Temperature: kept at 22 ± 1 °C
- Humidity: 60 ± 10 %
- Air changes: eight times/h.
- Photoperiod: light from 21.00 to 09.00.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied: aqueous solution
- Area of exposure: for skin application a site of 35 cm2 was clipped 3 h before administration.
- Type of wrap if used: the site covered by four-ply gauze and an elastic bandage (Acrylastic, Beiersdorf AG, FRG).

Duration of exposure:

14 days

Doses:

2000 mg/kg

No. of animals per sex per dose:

Groups of five animals of either sex

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 1, 2, 3 and 5 hours after dosing and each day for 14 days.
- Necropsy of survivors performed: yes, when surviving animals were killed.
- Other examinations performed: macroscopical examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: No signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

LD50 (rat) > 2000 mg/kg bw

Executive summary:

Rats were tested for dermal acute toxicity; for skin application a site of 35 cm² was clipped 3 hours before administration and the site covered by four-ply gauze and an elastic bandage. Test item was administered as 20 % suspension.

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 rats.

Conclusion

LD50 (rat) > 2000 mg/kg bw