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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Study period:
1982-06-01 to 1982-06-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
version 1982
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate
EC Number:
277-232-6
EC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate
Cas Number:
73019-09-7
Molecular formula:
C20H24N3.CH3O4S
IUPAC Name:
1,3,3-trimethyl-2-[methyl(4-methylphenyl)carbonohydrazonoyl]-3H-indolium methyl sulfate
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Weight at study initiation: average 2.3kg
- Housing: individually
- Diet (e.g. ad libitum): "mümmel z" ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg test substance mixed with water in a patch
Duration of treatment / exposure:
4h
Observation period:
8d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm patch
- Type of wrap if used: Leukoflex (R) and Eloflex (R)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water or olive oil
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48, 72h and 8d

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
because of colouring caused by test substance
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 observed
Other effects:
No irritating effect observed in discoloured skin areas

Any other information on results incl. tables

animal nr    observation time
24h 48h 72h
I erythema * * *
edema 0 0 0
II erythema * * *
edema 0 0 0
III erythema * * *
edema 0 0 0
* colouring caused by test substance

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is determined as not irritating to rabbit skin under the conditions of the test.