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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.