Registration Dossier

Administrative data

Description of key information

Nigrosin WLF is not irritating to the skin and not to the mucous membranes of the eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similiar to OECD guideline (instillation of only 50 mg , not 100 mg), no GLP
Qualifier:
according to
Guideline:
other: ETAD-Subkomitee für Toxikologie: Empfohlenen Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln
Principles of method if other than guideline:
Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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 ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as contol
Amount / concentration applied:
50 mg/animal
Duration of treatment / exposure:
no data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days., the opposite eye served as control.
Irritation parameter:
overall irritation score
Basis:
animal:
Time point:
other: up to 7 days
Score:
ca. 0
Max. score:
110
Remarks on result:
other: no irritation was observed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
no reactions were observed
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Application of 50 mg and not 100 mg test substance into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

SKIN IRRITATION

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.

EYE IRRITATION

Application of 50 mg test substance instead of 100 mg into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.


Justification for selection of skin irritation / corrosion endpoint:
only one study available

Justification for selection of eye irritation endpoint:
only one study available

Justification for classification or non-classification

based on the available data, no classification or labelling is required