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

Endpoint summary

Description of key information

Skin irritation: not irritant

Eye irritation: eye damage

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL- Amount applied: 0.5 g moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3 males

Details on study design:

TEST SITE- Area of exposure: 8 cm²- 2.5 x 2.5 cm large pieces of double-layer surgical gauze were filled with 500 mg of substance with water and fixed with a patch on the right side of the animals.REMOVAL OF TEST SUBSTANCE- Washing (if done): yes, with water- Time after start of exposure: 4 hoursSCORING SYSTEM: according to Draize

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Remarks on result:

other: not determined due to the coloring effect of the substance

Irritation parameter:

edema score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

no irritating effects

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal irritation/corrosion study according to OECD 404 the test substance was found to be non-irritating to the skin.

Executive summary:

In a primary dermal irritation study (OECD guideline 404), three male New Zealand white rabbits were dermally exposed to 0.5 g of the test item for 4 hours to a body surface area of 8 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48, 72 hours and 8 days and irritation was scored by the method of Draize. The test substance did not cause any skin effects and is considered under the conditions of this study as not irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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

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)

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of the test performed on BY29 and similar substances, the following classification is required:
Eye damage 1, H318.