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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
July 5th, 1983 - July 8th, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983
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)
GLP compliance:
no
Remarks:
but QAU statement included

Test material

Constituent 1
Chemical structure
Reference substance name:
2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
EC Number:
226-866-1
EC Name:
2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
Cas Number:
5521-31-3
Molecular formula:
C26H14N2O4
IUPAC Name:
2,9-dimethylisoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
- Physical state: solid (powder)
- technical grade
- Storage condition of test material: in the dark at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2013 breeding diet - rabbit (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): fully conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylenglycol 400
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg in 0.3 mL polyethylenglycol 400
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose gauze held in place with an adhesive plaster (Fa. Baiersdorf AG, Hamburg)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to OECD guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
0.5 - 1 hour after treatment, erythema score 1 was observed in 1/3 animals and edema score 1 was observed in 3/3 animals.
The treated skin was red colored from the test substance.
At 72 hours after treatment two animals showed a dry and rough skin.

Any other information on results incl. tables

Overview of Results:

Animal 1 Animal 2 Animal 3
erythema 1 h 0 1 0
24 h 1 0 0
48 h 0 0 1
72 h 0 0 0
edema 1 h 1 1 1
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was investigated for its potential to irritate the skin. Under the conditions chosen, the test substance was concluded to be not irritating.
Executive summary:

In the study 0.5 g of the test substance in 0.3 ml PEG 400 was applied to the skin of three New Zealand White rabbits in a study according to OECD guideline 404. The animals were observed for 72 hours. 0.5 - 1 hour after treatment, erythema score 1 was observed in 1/3 animals and edema score 1 was observed in 3/3 animals. The mean scores (24, 48 and 72 hours) for erythema and edema were 0.2 and 0, respectively. The treated skin was red coloured from the test substance. At 72 hours after treatment two animals showed a dry and rough skin. Based on the results of this study, the test article was considered to be not irritating to the skin.