Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
12 - 19 Mar 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: ETAD-Method
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
according to internal guideline 1552
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride
EC Number:
228-800-7
EC Name:
2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride
Cas Number:
6359-50-8
Molecular formula:
C22H25N2.Cl
IUPAC Name:
2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride
Test material form:
solid: particulate/powder
Details on test material:
Common name: Basic Yellow 21 chloride

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HACKING & CHURCHILL, Huntingdon England
- Weight at study initiation: 3 - 4kg
- Housing: individually in cages (MEISTER and SCHINDLER)
- Diet (e.g. ad libitum): rabbit feeding Z222 (Höing), ad libitum
- Water (e.g. ad libitum): water ad libitum

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg test substance per patch per animal
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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/corrosion observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of irritation related to the substance were observed on rabbit skin. The substance is not classifiable according to CLP criteria.