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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
other: see 'Remark'
Remarks:
Test procedure in accordance with national standard methods with acceptable restrictions, 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

Constituent 1
Chemical structure
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
IUPAC Name:
tris[4-(diethylamino)phenyl]methylium acetate
Details on test material:
- Name of test material (as cited in study report): fluessig

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 72h
Score:
4
Reversibility:
not reversible
Remarks on result:
other: short observation period (8 days)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 72h
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:
irritating
Remarks:
Migrated information