2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Source study has reliability 1; details on the read-across approach are attached in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1980

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK.
- Weight at study initiation: 2.9 kg.
- Accommodation: individual cages.
- Diet: ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C.
- Humidity: 40 - 60 %.
- Photoperiod: 12 hours light and 12 hours dark.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g test substance.

Duration of treatment / exposure:

4 hours.

Observation period:

14 days.

Number of animals:

3 females.

Details on study design:

TEST SITE
- Area of exposure: ca. 2.5 × 2.5 cm.
- Type of wrap if used: gauze, secured with an elastic, air-permeable adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: yes.
- Time after start of exposure: 4 hours.

SCORING SYSTEM

Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe eythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 no oedema
1 very slight oedema (barely perceptible)
2 slight oedema (edges of area well-defined by definite raising)
3 moderate oedema (raised approximately 1 mm)
4 severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 h

Score:

< 2.3

Remarks on result:

other: 14-d observation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 h

Score:

< 2.3

Remarks on result:

other: 14-d observation

Any other information on results incl. tables

animal no.	1h		24h		48h		72h		7d		14d
	o.	e.	o.	e.	o.	e.	o.	e.	o.	e.	o.	e.
1	0	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0	0
3	-	0	0	0	0	0	0	0	0	0	0	0

o. = oedema

e. = erythema

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

Under test conditions, the substance is not irritant to the rabbit skin.

Executive summary:

Method

Study in 3 female rabbits by semiocclusive application of test material under a composite patch on clipped skin. Upon a 4 -hour exposure to the test material, patches were removed and the skin was rinsed with water. Observation and scoring at 1h, 24 h, 48 h, 72 h, 7 d and 14 d after application were done based on the Draize scale (1940).

Result

Animals were observed for erythema and oedema. A score was associated to each animal, averaging over results at 24, 48 and 72 hours. None of the animals showed any observable response to treatment throughout the observation period.