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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: equivalent to OECD guideline study but no GLP: test substance was applied to the inner surface of the rabbit's ear instead to the rabbits's back

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ETAD Subkommitee für Toxikologie: : Empfohlene Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln"
Principles of method if other than guideline:
On the inner surface of one ear of each of 2 New Zealand White rabbits test substance was applied and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
EC Number:
291-454-0
EC Name:
Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
Cas Number:
90411-76-0
Molecular formula:
Mixture of components, no definitve molecular formula existing.
IUPAC Name:
Complex mixture of phenazine dyes - IUPAC name not available
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance:
commercial formulation, purity ca. 99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
body weight at the start of the study: 3-4 kg
one male and one female rabbit
housing individually
diet ad libitum
water ac libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: no preparing necessary
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite ear served as contol
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
24 hours
Observation period:
7 days post treatment
Number of animals:
2
Details on study design:
On the inner surface of one ear of each of 2 New Zealand White rabbits test substance was applied and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h - 7 d
Score:
ca. 0
Max. score:
8
Reversibility:
other: no effects observed
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
other: not determined
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
other: not determined
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
other: not determined
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
other: not determined
Irritant / corrosive response data:
not irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Instead of to the back of rabbits test substance was applied to the inner surface of one ear of each of

2 New Zealand White rabbits and fixed with a plaster for 24 hours. Afterwards the treatment area was washed with water and soap/plant oil and was observed for further 7 days . The opposite ear of each of the 2 rabbits served as control. No reaction of the skin was observed. Thus, Nigrosin WLF has to be evaluated as not irritating to the skin.