Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- and acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from NTRL reports

Data source

Reference

Reference Type:

secondary source

Title:

REPORT OF THE INDUSTRIAL TOXICOLOGY SCREENING STUDIES IN RATS, MICE AND RABBITS

Author:

NTRL

Year:

1992

Bibliographic source:

NTRL report, 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: BASF TEST and Draize test

Principles of method if other than guideline:

Primary dermal irritation study was performed in rabbits to assess the irritation potential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate

EC Number:

265-479-2

EC Name:

2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate

Cas Number:

65122-08-9

Molecular formula:

C25H29N2.C2H3O2

IUPAC Name:

1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate - Common Name: Basic Red 12 acetate- Molecular formula:C25H29N2C2H3O2- Molecular weight:416.562 g/mol- Substance type:Organic- Physical state:Solid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: GAUKLER 6050 OFFENBACH/ maIN- Age at study initiation:no data- Weight at study initiation: rabbit 1- 3.68 kg, rabbit 2- 3.67 kg and rabbit 3- 2.97 kg- Fasting period before study:no data- Housing: stainless steel cages with GRADE GROUND FLAT 40 CM * 50 cm- Diet (e.g. ad libitum): STANDARDIET FOR RABBIT 4mm; FA. SSNIFF-VERSUCHSDIAETEN GmbH, ~ 770 SOEST (Approximately 130 G PER ANIMALS)- Water (e.g. ad libitum): approx 250ml per rabbit, water (monday - friday), tap water (saturday - sunday)- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): 20-26 deg C- Humidity (%):50- 80%- Air changes (per hr):no data- Photoperiod (hrs dark / hrs light): 12h/12 H (6.00 - 18.00 UHR/16.00 - 6.00 UHR)

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and scarified skin

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5 ml undiluted sample

Duration of treatment / exposure:

4 hours

Observation period:

15-30 minutes after patch removal, then 48,72 hours till 8 days.

Number of animals:

3 (2 male and 1 female)

Details on study design:

Area of exposure: back of each rabbits% coverage: 2.5 cm * 2.5 cm patch- Type of wrap if used: occlusive wrapSCORING SYSTEM: Draize method

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 8 day

Score:

3.9

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

Moderate to severe skin irritation along with tissue degeneration (necrosis) was noted in the rabbits.

Any other information on results incl. tables

Table: Skin irritation score

Animal no.	4 hours		Day 1		Day 2		Day 8
	Redness	edema	Redness	edema	Redness	edema	Redness	edema
1	*	2	*	4 O	*	3O	*s	2
2	*	2	*	3	*	3O	*s	1
Redness : 1= questionable; 2= slightly; 3=strongly; 4=very strongly Edema : 1= very slightly; 2=slightly; 3=strongly; 4=very strongly   O=Overlapping, S=scale formation *=exact reading were not possible due to the coloring of skin

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The observed primary irritation score after 8 days was ≥3.9Moderate to severe skin irritation along with tissue degeneration (necrosis) was noted in the rabbits.Based on the scores and observations,the test chemical was considered to be moderate to strongly irritatingto the rabbits’ skin.

Executive summary:

Primary dermal irritation study was performed in rabbits according to BASF TEST and Draize test methods to assess the irritation potential of the test chemical

3 (2 male and 1 female) albino Vienna White rabbits were used for the study.0.5 ml undiluted sample was applied to intact and scarified back skin of rabbits under occlusion. The untreated skin sites served as control. The occlusive patches were removed after 4 hours and the test sites. The sites were observed for signs of irritation15-30 minutes after patch removal, then 48, 72 hours till 8 days. The reactions were scored according to Draize method.

The observed primary irritation score after 8 days was ≥3.9

Moderate to severe skin irritation along with tissue degeneration (necrosis) was noted in the rabbits.

Based on the scores and observations,the test chemical was considered to be moderate to strongly irritatingto the rabbits’ skin.