[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

study well documented; significance limited due to substance-induced coloration of the skin, which didn't allow correct reading of skin reactions; skin reactions could be caused by other components of the product (acetic acid).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Method: Draize Test according to: Federal Register 38, No. 187, §1500.41, p.27019 of Sep 27, 1973

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tris[4-(diethylamino)phenyl]methylium acetate

EC Number:

263-974-8

EC Name:

Tris[4-(diethylamino)phenyl]methylium acetate

Cas Number:

63157-72-2

Molecular formula:

C31H42N3.C2H3O2

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: female: 3.1 kg/ male: 3.2 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

24 hour(s)

Observation period:

8 days

Number of animals:

6 (4 male/2 female)

Details on study design:

The undiluted test substance was applied to a 2.5 x 2.5 cm patch (0.5 ml) .

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal:

Time point:

24/48/72 h

Score:

4

Reversibility:

not reversible

Remarks on result:

other: short observation period (8 days)

Results 2

Irritation parameter:

edema score

Basis:

animal:

Time point:

24/48/72 h

Score:

> 1.83 - < 2.17

Reversibility:

not reversible

Remarks on result:

other: short observation period (8 days)

Any other information on results incl. tables

SKIN FINDINGS AFTER 24 AND 72 HOURS:

	Skin	Time	Animal No.
			1	2	3	4	5	6
Erythema	Intact	24 h	*	*	*	*	*	*
		72 h	*	*	*	4	*	*
	Abraded	24 h	*	*	*	*	*	*
		72 h	*	4	*	*	*	*
Edema	Intact	24 h	2	2	2	2	3	2
		72 h	2	2	2	0	3	2
	Abraded	24 h	3	3	3	3	3	3
		72 h	3	3	3	3	3	2

* The irritation index could not be calculated exactly due to substance-induced coloration of the skin. Primary irrition index of the skin: 17.83/4 = 4.46.

 

SKIN FINDINGS AFTER 8 DAYS:

Animal No.	Inctact	Abraded
1	Scaling	Superficial necrosis with crusts
2	Severe scaling	Superficial necrosis with crusts
3	Erythema +, spotted	Superficial necrosis with crusts
4	Superficial necrosis with crusts	Superficial necrosis with crusts
5	Superficial necrosis with crusts	Superficial necrosis with crusts
6	Superficial necrosis with crusts	Necrosis with crusts

Individual scores for erythema could not be determined due to substance-induced coloration of the skin. The mean edema score (24, 72 h) was 1.3 in 1 of 6 animals, 2.0 in 4 of 6 animals and 3.0 in 1 of 6 animals. At the end of the observation period (day 8) scaling (in 2 animals) or superficial necrosis with crusts (in 3 animals) was observed. Only cutaneous effects observed after treatment of intact skin are considered relevant for hazard assessment and are described in detail.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant) based on CLP criteria

Conclusions:

The substance was tested following an internal procedure Draize test. The substance was tested following an itnernal procedure Draize test. Under the experimental conditions the substance showed an high erythema (>4) score and a moderate edema.

Executive summary:

The substance was tested following an internal procedure Draize test. Six NZW rabbits (4 males and 2 females) were expsoed to the tested substance in a patch test for 24 hours and observed for 8 days. Under the experimental conditions the substance showed an high erythema score (ca. 4) and a moderate edema.