Registration Dossier
Registration Dossier
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EC number: 937-559-3 | CAS number: 1360085-10-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- sodium 7-[(ethoxycarbonyl)amino]-4-hydroxynaphthalene-2-sulfonate
- EC Number:
- 937-559-3
- Cas Number:
- 1360085-10-4
- Molecular formula:
- C13H12NNaO6S
- IUPAC Name:
- sodium 7-[(ethoxycarbonyl)amino]-4-hydroxynaphthalene-2-sulfonate
- Details on test material:
- 85.2 % active substance
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted) delivered by BRL
- Sex:
- female
- Details on test animals and environmental conditions:
- 30 females
Results and discussion
Any other information on results incl. tables
ERYTHEMATOUS REACTIONS AFTER THE CHALLENGE PROCEDURE (TEST GROUP)
after 24 h after 48 h
positive/total positive/total
0/20 3/20
No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- the tested substance at concentration of 75% in bi-distilled water is considered to be
a non-sensitizer when described under the test conditions. - Executive summary:
not sensitising
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