Registration Dossier
Registration Dossier
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EC number: 433-990-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start: 1999-12-13 End: 2000-01-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vivo test performed in 1999-2000.
Test material
- Reference substance name:
- 4-(2-{2,4-dihydroxy-5-[2-(4-hydroxyphenyl)propan-2-yl]phenyl}propan-2-yl)phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
- Molecular formula:
- C34H30N2O7S
- IUPAC Name:
- 4-(2-{2,4-dihydroxy-5-[2-(4-hydroxyphenyl)propan-2-yl]phenyl}propan-2-yl)phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
- Reference substance name:
- 4-[2-(2,4-dihydroxy-5-{2-[4-({[6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl]propan-2-yl}phenyl)propan-2-yl]phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
- Molecular formula:
- C44H34N4O10S2
- IUPAC Name:
- 4-[2-(2,4-dihydroxy-5-{2-[4-({[6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl]propan-2-yl}phenyl)propan-2-yl]phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
- Test material form:
- solid
- Details on test material:
- Batch PW-9F-29
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks
- Weight at study initiation:
- control animals: 359 - 393 gram
- test animals: 334 - 412 gram
- Housing: group housing of 5 animals per labelled metalcage with wire-mesh Íloors
- Diet: ad libitum, standard guinea pig diet, including ascorbic acid (1000 mg/kg); (Charles River Breeding and Maintenance Diet Íor Guinea Pigs, Altromin, Lage, Germany).
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 10 %w/w
- Day(s)/duration:
- Day 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50 %w/w
- Day(s)/duration:
- 48h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 %w/w
- Day(s)/duration:
- 24h
- No. of animals per dose:
- treatment: 10
control: 5 - Details on study design:
- RANGE FINDING TESTS:
Based on the results of the preliminary irritation study, the test substance concentrations selected for the main study were a 10% concentration for the intradermal induction and a 50% concentration for the epidermal induction exposure.
No signs of irritation were observed to the highest test substance concentration epidermally tested. Therefore, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction.
A 50% test substance concentration was selected for the challenge phase. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamic aldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10 %w/w
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Not concurrent test
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 % w/w
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Not cioncurrent test
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitization rate of 0 per cent.
- Executive summary:
Test substance concentrations selected for the main study were based on the results of a preliminary study. ln the main study, ten experimental animals were intradermally injected with a 10% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (polyethylene glycol). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all anímals were challenged with a 50% test substance concentration and the vehicle.
There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitization rate of 0 per cent.
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