Registration Dossier
Registration Dossier
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EC number: 701-171-0 | 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:
- February - March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 406 guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- non-LLNA method was performed because the study was performed in 1997 i.e before the publication of the LLNA (guideline OECD 429 adopted in 2002)
Test material
- Reference substance name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
- EC Number:
- 915-333-5
- IUPAC Name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: 381 - 490 g
- Housing: 2 or 3 animals per wire cage (40.5 x 38.5 x 18 cm) with a stainless steel feeder
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): approximately 20
- Photoperiod (hrs dark / hrs light): 12 / 12 (7 a.m. / 7 p.m.)
IN-LIFE DATES: From: February 3, 1997 To: March 21, 1997
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 75% (w/v) for both induction and challenge phases (0.3 mL per patch)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 75% (w/v) for both induction and challenge phases (0.3 mL per patch)
- No. of animals per dose:
- 20 (treated) + 10 (control)
- Details on study design:
- RANGE FINDING TESTS:
In a preliminary test on 2 animals, the concentrations of 25, 50 and 75% (w/v) of test substance were tested for their irritation potential and applied to the skin as an occlusive patch for 6 hours. All animals were observed for up to 48 hours for local reactions at the application sites. All three concentrations tested were well tolerated and exerted no irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (days 0, 6 and 13)
- Exposure period: 6 hours
- Test group: Test substance
- Control group: Vehicle
- Site: 6 x 6 cm clipped skin area on left flank
- Frequency of applications: single applications
- Duration: 13 days
- Concentrations: 75% (w/v) in acetone
B. CHALLENGE EXPOSURE
- No. of exposures: Single application
- Day(s) of challenge: Day 27
- Exposure period: 6 hours
- Test groups: Test substance (posterior flank) + Vehicle (anterior flank)
- Control group: Test substance (posterior flank) + Vehicle (anterior flank)
- Site: 6 x 6 cm clipped skin area on right flank
- Concentrations: 75% (w/v) in acetone
- Evaluation (hr after challenge): 24 hours after 6-h challenge
OTHER: Not applicable - Challenge controls:
- 10 male animals were challenged with both test substance (right posterior flank) and vehicle alone (right anterior flank)
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Male No. 3 died of acute enteritis on day 27
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Male No. 3 died of acute enteritis on day 27
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No sensitizing potential was detected in a Buehler test at 75% (w/v) in acetone.
The test substance was therefore not classified for skin sensitisation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS. - Executive summary:
In a dermal sensitization study (RBM study No. 970076) with Tristyrenated phenol/Distyrenated phenol (75/25 molar %) in acetone, 6-week old Dunkin-Hartley Guinea-pigs (20 test and 10 control males) were tested using the method of Buehler. Topical induction was performed applying test substance at 75% (w/v) in acetone (test animals) or vehicle alone (control animals) to a left flank clipped skin area on days 0, 6 and 13. Challenge application with both test substance at 75% (w/v) and vehicle alone was performed on a right flank clipped skin area on day 27. Local reactions were assessed 24 and 48 hours later.
One test animal died on day 27, but this death bore no relationship with test substance. No cutaneous reactions were observed in any of the test or control animals following challenge.
In this study, TSP/DSP at the concentration of 75% (w/v) was not a dermal sensitizer using the non-adjuvant Buehler test method.
TSP/DSP is not classified for skin sensitisation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.
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