Registration Dossier
Registration Dossier
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EC number: 943-697-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Parameters analysed / observed: erythema.
- Application: dorsal skin and ears. - GLP compliance:
- no
- Remarks:
- Pre 1981
Test material
- Reference substance name:
- Iron, complexes with diazotized 2-amino-4,6-dinitrophenol coupled with diazotized 4-nitrobenzenamine and 4-[(2,4-dihydroxyphenyl)azo]-5-hydroxy-2,7-naphthalenedisulfonic acid, sodium salts
- EC Number:
- 289-124-6
- EC Name:
- Iron, complexes with diazotized 2-amino-4,6-dinitrophenol coupled with diazotized 4-nitrobenzenamine and 4-[(2,4-dihydroxyphenyl)azo]-5-hydroxy-2,7-naphthalenedisulfonic acid, sodium salts
- Cas Number:
- 86014-76-8
- IUPAC Name:
- Acid Brown 165
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Vehicle:
- water
- Remarks:
- 50 % preparation
- Duration of treatment / exposure:
- 1, 5, 15 minutes and 20 hours for dorsal skin.
20 hours for ears. - Observation period:
- 8 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 1, 5 and 15 minutes application
- Time point:
- 24 h
- Reversibility:
- other: no dermal effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 20 hours application
- Time point:
- 24 h
- Reversibility:
- other: yellow substance remainders
- Remarks on result:
- not determinable
- Irritation parameter:
- erythema score
- Remarks:
- 20 hours application
- Time point:
- other: 8 days
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- overall irritation score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritant
- Conclusions:
- Not irritating.
- Executive summary:
Dorsal skin and ears of rabbits were exposure to the substance at different time of exposures. At the highest tested exposure time (i.e. 20 hours application), after 24 hours observation, erythema score could not be assessed, due to remainders of yellow color of the substance. After 8 days, no sign of irritation was observed.
At the lower tested exposure time, no signs of irritation were observed.
Conclusion
The substance is not a skin irritant.
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