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Registration Dossier
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EC number: 276-982-1 | CAS number: 72905-97-6
Skin irritation / corrosion
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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- EC Number:
- 276-982-1
- EC Name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- Cas Number:
- 72905-97-6
- Molecular formula:
- C44H24Cu2N8O17S4.xNa xNH4, x=0~4 , typical x=2
- IUPAC Name:
- Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium
- Details on test material:
- Purity: 95.2%
Constituent 1
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.
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