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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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 Toxico l1984) 56: 43-45.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

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 / tissue source

Species:

rabbit

Strain:

other: CPH

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: from Statens Sevlmlnstimt, (Copenhagen, Denmark).
- Weight at study initiation: 2.7 kg.

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Concentration: 100 µl.
- Application: aqueous solution (76 mg/kg) was deposited in the lower conjunctival sack of the left eye.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

Three rabbits + one

Details on study design:

Three rabbits were treated with 8 % aqueous solution; a further single rabbit was treated with fine crystals (particle size 60-90 µm).

TOOL USED TO ASSESS SCORE: examinatious carried out with an ophthalmoscope and 1 % sodium fluorescein solution.

Results and discussion

In vivo

Results

Remarks on result:

other: results are reported in the other sections

Irritant / corrosive response data:

Instillation of 8 % aqueous solution produced marked edema, substantial discharge and slight hyperemia of the conjunctiva which disappeared after 24 h in two out of three rabbits. No effect on cornea or iris was observed and all were fully restituted after 8 days.
The rabbit treated with fine crystals showed a totally opaque cornea and bright red and edemateous conjunctivae which remained for a forthnight.

Any other information on results incl. tables

.

Applicant's summary and conclusion

Interpretation of results:

other: Eye Dam. 1 (H318), according to the CLP Regulation (EC 1272/2008)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Eye Dam. 1, H318

Executive summary:

100 µl of Malachite Green Oxalate was deposited in the lower conjunctival sack of the left eye while the fight eye served as a control. Treatment and observations were in accordance with the OECD guidelines (1981), and examlnatious carried out with an ophthalmoscope and 1 % sodium fluorescein solution. Instillation of 8 % aqueous solution produced marked edema, substantial discharge and slight hyperemia of the conjunctiva which disappeared after 24 h in two out of three rabbits. No effect on cornea or iris was observed and all were fully restituted after 8 days.

A single rabbit was treated with fine crystals (particle size 60-90 µm) which produced a totally opaque cornea and bright red and edemateous conjunctivae which remained for a forthnight.

Conclusion

An harmonized classification and labelling (C&L) has already been approved for Malachite Green chloride (EC: 209-322-8) and oxalate (EC: 219-441-7) salts. The classifications have been discussed by Commission of the European Communities and the related information was presented in ECBI/54/02 report, 18th July, 2002 (Health and Safety Executive, UK. 2005). In this context, the current study outcomes have been reviewed and the effects occurring in the rabbit treated with fine crystals were judged as sufficient to support the current classification: Xi; R41 (corresponding to Eye Dam. 1, H318 of the CLP Regulation (EC 1272/2008).