1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-09-12 to 1989-10-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

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:

1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride

EC Number:

268-750-3

EC Name:

1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride

Cas Number:

68134-38-3

Molecular formula:

C20H24ClN3

IUPAC Name:

1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Hagemann Gmbh&Co- Weight : 2.3 kg (medium)- Housing: individually cages- Diet: "Mummel Z" (Ssniff Spezialdiäten GmbH, Soest)- Water: tap water ad libitum consultion- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 216-18- Humidity (%): ca. 40 - Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 µL

Duration of treatment / exposure:

1 second eye lids gently close

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE: the treated eyes were not rinsedSCORING SYSTEM: according to Draize and McDonals and ShadduckTOOL USED TO ASSESS SCORE: fluorescein in ophtalmological solution (1 drop)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: all animals showed effetcs

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: all animals showed effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

3

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: all animals showe effects

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: all animals showed a mean chemosis score of 4

Irritant / corrosive response data:

All animals showed strong effect on cornea, iris and conjunctivae.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

In an acute eye irritation/corrosion study according to OECD 405, the test substance causes severe eye-irritating effects.

Executive summary:

In a primary eye irritation study, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three male New Zealand White rabbits. The animals were observed for a period of 8 days.
In this study, the test item is corrosive to the eye based on effects on conjunctivae, cornea and iris.