Registration Dossier
Registration Dossier
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EC number: 300-644-5 | CAS number: 93951-21-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17. Nov to 18. Dec 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was already available
Test material
- Reference substance name:
- Tetrasodium 4-amino-5-hydroxy-3,6-bis[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
- EC Number:
- 241-164-5
- EC Name:
- Tetrasodium 4-amino-5-hydroxy-3,6-bis[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
- Cas Number:
- 17095-24-8
- Molecular formula:
- C26H25N5O19S6.4Na
- IUPAC Name:
- Tetrasodium 4-amino-5-hydroxy-3,6-bis[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate
- Details on test material:
- Preparation of Reaktiv Schwarz 5: Remazol Schwarz B flüssig 50
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 240 to 334 g
- Housing: group-housing (5/cage)
- Diet: ERKA Nr 8300 ad libitum
- Water: tap water ad libitum
- Acclimation period: ca. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17. Nov To: 18. Dec 1987
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% / 0.1 mL per injection
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.5 mL
- Day(s)/duration:
- Day 8 for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.5 mL
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10 - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- blue staining of skin
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- blue staining of skin
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- blue staining of skin
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- blue staining of skin
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not sensitizing in pirbright white guinea pigs.
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