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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
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 95.2%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.