Registration Dossier
Registration Dossier
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EC number: 405-520-5 | CAS number: 95235-30-6 D-8; DD-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-05-02 to 1986-07-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA study was conducted as an in vivo study according to OCED 406 was conducted in 1989, before the first version of the LLNA (OECD 429) was issued in 2002.
Test material
- Reference substance name:
- 4-(4-isopropoxyphenylsulfonyl)phenol
- EC Number:
- 405-520-5
- EC Name:
- 4-(4-isopropoxyphenylsulfonyl)phenol
- Cas Number:
- 95235-30-6
- Molecular formula:
- C15H16SO4
- IUPAC Name:
- 4-[4-(propan-2-yloxy)benzenesulfonyl]phenol
- Details on test material:
- - Name of test material (as cited in study report): D - 8
- Molecular formula: C15 H16 O4 S;
- Molecular weight: 292.4;
- Physical state: white powder;
- Analytical purity: > 99.5 %;
- Purity test date: not stated;
- Lot/batch No.: Not stated;
- Expiration date of the lot/batch: not stated;
- Stability under test conditions: stable at ambient temperature and conditions;
- Storage condition of test material: store in a cool dry place, protected from direct sunlight;
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall; Newchurch, Staffordshire, England;
- Age at study initiation: not indicated;
- Weight at study initiation: mean 430 - 440 g;
- Housing: suspended cages with wire mesh floors;
- Diet: Vitamin C-enriched Guinea pig diet F.D.1.; Supplier: Special Diets Services Limited; ad libitum;
- Water: tap water, ad libitum;
- Acclimation period: not indicated;
ENVIRONMENTAL CONDITIONS
- Temperature: approx. 21 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: approx. 15 air changes/hour
- Photoperiod: 12 hours light/12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Intradermal injection: 7.5 % w/w in Alembicol D;
Topical application: 50 % w/w in Alembicol D;
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 50 % and 20 % w/w in Alembicol D;
- No. of animals per dose:
- 20 test animals
20 control animals - Details on study design:
- The method employed in this study for the detection of delayed contact hypersensitivity was the guinea-pig maximisation test described by B. Magnusson and A.M. Kligman.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not tested
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:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- 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:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- D-8 was tested for delayed hypersensitivity in the guinea-pig according to the EU Guideline B.6 and OECD 406. D-8 did not produce any evidence of delayed contact hypersensitivity.
- Executive summary:
D-8 was tested for delayed hypersensitivity using the Magnusson-Kligman Test in guinea pigs. Test animals were induced by intradermal (7.5% w/w) and topical application (50% w/w) of D-8 in Alembicol 8, a coconut oil derived solvent for dermal applications. Two weeks after the induction period, the animals were challenged by dermal application of the test item. The evaluation after 24, 48 and 72 hours after removal of the test substance showed no evidence of delayed hypersensitivity caused by the test item. In conclusion, D-8 was considered non-sensitizing in contact with skin.
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