1,3,3-trimethyl-2-[(methylphenylhydrazono)methyl]-3H-indolium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1982-06-01 to 1982-06-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

version 1982

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

277-232-6

EC Name:

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

Cas Number:

73019-09-7

Molecular formula:

C20H24N3.CH3O4S

IUPAC Name:

1,3,3-trimethyl-2-[methyl(4-methylphenyl)carbonohydrazonoyl]-3H-indolium methyl sulfate

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Weight at study initiation: average 2.3kg
- Housing: individually
- Diet (e.g. ad libitum): "mümmel z" ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg test substance mixed with water in a patch

Duration of treatment / exposure:

4h

Observation period:

8d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm patch
- Type of wrap if used: Leukoflex (R) and Eloflex (R)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water or olive oil
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48, 72h and 8d

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Max. score:

4

Remarks on result:

not determinable

Remarks:

because of colouring caused by test substance

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation observed

Other effects:

No irritating effect observed in discoloured skin areas

Any other information on results incl. tables

animal nr		observation time
		24h	48h	72h
I	erythema	*	*	*
	edema	0	0	0
II	erythema	*	*	*
	edema	0	0	0
III	erythema	*	*	*
	edema	0	0	0
* colouring caused by test substance

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is determined as not irritating to rabbit skin under the conditions of the test.