2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

12. to 19. Sep 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, the tested substance is the methyl sulfate salt of the registered substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate

EC Number:

258-946-7

EC Name:

2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate

Cas Number:

54060-92-3

Molecular formula:

C20H24N3O.CH3O4S C21H27N3O5S

IUPAC Name:

2-{[2-(4-methoxyphenyl)-2-methylhydrazin-1-ylidene]methyl}-1,3,3-trimethyl-3H-indol-1-ium methyl sulfate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Astrazon Goldgelb GLN trocken

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: -
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: single
- Diet: "Ssniff K 4" (Ssniff Spezialdiaten GmbH, Soest), approx 100-120 g per animal and day feeding once per day in the morning
- Water: tap water was available for ad libitum consultion (between 7 and 19 hrs from automatic watering apparatus)
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): ca. 50 %
- Air changes (per hr): ca 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 12. to 19. Sep 1989

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µl pulverized test substance = ca. 60 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours


SCORING SYSTEM: according to Draize ( see attachment) and McDonals and Shadduck


TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1 to 3

Time point:

other: 24 to 72 h

Score:

2 - 4

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

animal: 1 to 3

Time point:

other: 24 to 72 h

Score:

1 - 1.3

Max. score:

2

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 1 to 3

Time point:

other: 24 to 72 h

Score:

2.3 - 2.7

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 to 72 h

Score:

4

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

The mucous membranes became whitishly discolored after 24 hours in two animals. One day thereafter all rabbits showed this discoloration. 72 hours following exposure necrosis of the conjunctivae was observed in all animals. In one rabbit the nictitating membrane was blood-covered. Discharge became white-yellowishly discolored in two animals. Since these findings had to be considered as irreversible animals were sacrificed after 72 hours.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results the test substance can be regarded as 'corrosive to the eye'. Exposure of the test substance to the eye resulted in significant tissue destruction (necrosis). These evidences indicate a corrosive potential of the product to the eye.