Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating.
Eye irritation: not irritating.

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
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Duration of treatment / exposure:
The right and left flank of animals was shaved at area about 6 x 6 cm.
The test sample 0.5 g, moistened with water, was applied on intact skin to 3 experimental animals. The test sample was covered by gauze, foil and cellulose wool. Cotton was held in place with technical tape so that the test sample was in contact with skin. Scarification was performed with using scarify needle (without bleeding). The test sample was applied on scarified skin by the same way as on intact skin. At the end of 4 hours exposition, dressing with the test sample was removed.
Observation period:
Rabbits were examined for signs of erythema and oedema at 1, 24, 48 and 72 hr after patch removal.
Number of animals:
3 females and males
Irritation parameter:
erythema score
Basis:
animal: 13
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: Intact skin, mean of all observation
Irritation parameter:
edema score
Basis:
animal: 13
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: Intact skin, mean of all observation
Irritation parameter:
erythema score
Basis:
animal: 14
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin, mean of all observation
Irritation parameter:
edema score
Basis:
animal: 14
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin, mean of all observation
Irritation parameter:
erythema score
Basis:
animal: 15
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: Intact skin, mean of all observation
Irritation parameter:
edema score
Basis:
animal: 15
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin, mean of all observation
Irritation parameter:
erythema score
Basis:
animal: 13
Time point:
other: overall at 1, 24, 48 and 72 hr
Score:
0.75
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: Scarified skin, mean of all observation
Irritation parameter:
edema score
Basis:
animal: 13
Time point:
other: overall at 1, 24, 48 and 72 hr
Score:
0.75
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: Scarified skin, mean of all observation
Irritation parameter:
erythema score
Basis:
animal: 14
Time point:
other: overall at 1, 24, 48 and 72 hr
Score:
0
Max. score:
0
Remarks on result:
other: Scarified skin, mean of all observation
Irritation parameter:
edema score
Basis:
animal: 14
Time point:
other: overall at 1, 24, 48 and 72 hr
Score:
0
Max. score:
0
Remarks on result:
other: Scarified skin, mean of all observation
Irritation parameter:
erythema score
Basis:
animal: 15
Time point:
other: overall at 1, 24, 48 and 72 hr
Score:
0.75
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: Scarified skin, mean of all observation
Irritation parameter:
edema score
Basis:
animal: 15
Time point:
other: overall at 1, 24, 48, 72 hr
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: Scarified skin, mean of all observation

Clinical examination of intact skin

Very slight erythema without oedema was observed in one animal 1 hour after patch removal. Very slight erythma was observed in the 2ndanimal and in the 3rdanimal no changes were observed.

No changes were observed in all animals in next time intervals.

Examination of scarified skin

Slight erythema and slight oedema were observed in one animal 1 hour after patch removal. Slight erythema and very oedema were observed in next one animal and in the 3rdanimal no changes were observed.

Very slight erythema and very slight oedema were observed in one animal 24 hrs after patch removal. Very slight erythema without oedema in next one animal and no changes in the 3rdanimal were recorded in 24 hrs.

No changes were observed in all animals in next time intervals.

RESULT

The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.
Executive summary:

Direct black 112 was tested for the dermal irritation. 3 male and female New Zealand Albino breed rabbits were used for the study. The test substance was exposed to skin for 4 hours. The examination for sign of erythema and oedema is at 1, 24, 48 and 72 hour after patch removal.

For the intact skin, very slight erythema was observed in 2 rabbits 1 hr after patch removal. No changes were observed in all animals in next time intervals.

For the sacrified skin, Slight erythema and slight oedema were observed in 2 animals 1 hour after patch removal. Very slight erythema and oedema were observed in one animal 24hrs. Very slight erythema without oedema in next one. No changes were observed in all animals in next time intervals.

The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.

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
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Controls:
yes
Duration of treatment / exposure:
3 male and female rabbits (New Zealand Albino breed) were more than 2.5 kg. No signs of diseases were observed at clinical check-in.
The test sample (0.1 g) was placed into the conjunctival sac of left eye of animal after gently pulling the lower lid away from the ball. After application the lids were gently held together for a few seconds. The right untreated eye served as a control. Three animals were used in test.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after application. In 1 hour after test sample application, the eye reaction was examined without rinse of water. In 24 hours, reaction of eye gently rinsed with water was performed. Examination of damage of cornea was performed using 2% solution of fluorescein. Examination of eye reaction in 48 hours was performed without fluorescein. Examination in 72 hours was performed using 2% fluorescein.
Number of animals or in vitro replicates:
3 male and female rabbits (New Zealand Albino breed)
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 hr
Score:
0
Max. score:
0
Remarks on result:
other: Mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
corena area
Basis:
animal: 38
Time point:
other: overall 24, 48 and 72 hr
Score:
0
Max. score:
0
Remarks on result:
other: Mean of all observation
Irritation parameter:
iris score
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
congestion
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72hr
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: 38
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 39
Time point:
other: overall 24, 48 and 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
area
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
iris score
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
congestion
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: 39
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
cornea opacity score
Remarks:
area
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
iris score
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
congestion
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
chemosis score
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: mean of all observation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal: 40
Time point:
other: overall at 24, 48 and 72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: mean of all observation

The following clinical signs were observed 1 hour after application: in one animal – congested conjunctiva (middle), strong serosal discharge colored by the test sample, in two animals: oedema of lids, strong serosal discharge; congestion of conjunctiva was not evaluated by the reason of coloring by the test sample.

The following clinical signs were observed 24 hours after application: in one animal – smoke opacity of cornea, congested conjunctiva (middle) and serosal discharge, oedema of lids (middle), serosal discharge (middle), in one animal slightly congested conjunctiva were recorded.

Examination in 48 hours after application showed very slight congestion of conjunctiva and in one animal slight congestion of conjunctiva.

Examination in 72 hours after application showed very slight congestion of conjunctiva and very slight discharge in one animal; in two animals no finding were recorded.

Interpretation of results:
GHS criteria not met
Conclusions:
The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.
Executive summary:

The sample, Direct black 112, was tested for the eye irritation. 3 New Zealand Albino males and females rabbits were applied with 0.1 g Direct black 112 on the conjunctival sac of left eye of animals. Most of the effects were observed at conjunctiva within 48 hrs. Almost no effect was observed 72 hours after treatment, only slight congestion of conjunctiva and very slight discharge in one animal.

The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Direct black 112 was tested for the dermal irritation. 3 male and female New Zealand Albino breed rabbits were used for the study. The test substance was exposed to skin for 4 hours. The examination for sign of erythema and oedema is at 1, 24, 48 and 72 hour after patch removal. For the intact skin, very slight erythema was observed in 2 rabbits 1 hr after patch removal. No changes were observed in all animals in next time intervals.

The test sample, Direct black 112, is not irritant for skin of rabbit according to CLP regulation 1272/2008.

The sample, Direct black 112, was tested for the eye irritation. 3 New Zealand Albino males and females rabbits were applied with 0.1 g Direct black 112 on the conjunctival sac of left eye of animals. Most of the effects were observed at conjunctiva within 48 hrs. Almost no effect was observed 72 hours after treatment, only slight congestion of conjunctiva and very slight discharge in one animal.

The test sample, Direct black 112, is not irritating to eyes, according to CLP regulation 1272/2008.

Justification for classification or non-classification

Based on the available data, the substance is not classified for skin irriation and eye irritation

according to CLP regulation 1272/2008.