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Registration Dossier
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EC number: 274-570-6 | CAS number: 70321-86-7
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (adopted in 1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Carried out according to the maximization test of Magnusson and Kligman (J. Invest. Dermatol. 52, 268-276, 1969).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this test was performed, the LLNA did not yet exist.
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol
- EC Number:
- 274-570-6
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol
- Cas Number:
- 70321-86-7
- Molecular formula:
- C30H29N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4,6-bis(2-phenylpropan-2-yl)phenol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Source: no data
- Batch No.: EN 24705
- Purity: techn. qual.
- Appearance: white powder
- Validity: 12/1984
- Stability under the condition of administration: not determined
Constituent 1
- Specific details on test material used for the study:
- - Batch No.: EN 24705
- Purity: techn. qual.
- Appearance: white powder
- Validity: 12/1984
- Stability under the condition of administration: not determined
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba Geigy AG
- Age at study initiation: ca. 10 wks
- Weight at study initiation: 328 - 468 g
- Housing: individually in macrolon cages (type 3)
- Diet: ad libitum; guinea pig pellets (NAFAG No. 846, Gossau SG), feed was supplemented with fresh carrots
- Water: ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14/10
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sesame oil (intradermal induction), vaseline (epicutaneous induction and challenge)
- Concentration / amount:
- Intradermal induction: 1 %
Epicutaneous induction: 30 %
Challenge: 30 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil (intradermal induction), vaseline (epicutaneous induction and challenge)
- Concentration / amount:
- Intradermal induction: 1 %
Epicutaneous induction: 30 %
Challenge: 30 %
- No. of animals per dose:
- 20 (10 males + 10 females)
- Details on study design:
- PRELIMINARY TEST: The concentrations of the test compound for the induction and challenge period were determined on separate animals.
MAIN STUDY
A. INDUCTION EXPOSURE
A1. Intradermal Injection
- Site of injection: neck
- Number of injections: 2/ formulation
- Formulations: 1). mixture of adjuvant and saline, 2). test compound in sesame oil (test group) or sesame oil (control group), 3). test compound in the adjuvant saline mixture (test group) or adjuvant saline mixture without test compound (control)
- Volume per injection: 0.1 mL/ formulation
- Evaluation (hr after injection): no data
A2. Epicutaneous induction exposure:
- Time schedule: one week after intradermal inductions
- Site: same as intradermal injections (site was pretreated the day before with 10% sodium lauryl sulphate: open application)
- Concentrations: 30 % (test group), and vehicle (control group)
- Volume applied: no data
- Type of coverage: occlusive
- Duration: 48 hours
- Evaluation (hr after challenge): no data
B. CHALLENGE EXPOSURE (identical treatment for treated and control animals)
- Time schedule: two weeks after topical induction
- Site: flank (one flank: test substance) other flank (vehicle)
- Vehicle: vaseline
- Concentrations: 30 %
- Volume applied: no data
- Type of coverage: occlusive
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure.
- Evaluation method: Draize scoring - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain is controlled every six months with p - phenylenediamine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 % in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 % in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 % in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 % in vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % in vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Body weights were taken before the start of the treatment and at termination.
Control animals
- At start: Mean (n = 20) = 380.7 +/- 36.66 g
- At termination: Mean (n = 20) = 528.4 +/- 68.74 g
Test group animals
- At start: Mean (n = 20) = 383.3 +/- 31.65 g
- At termination: Mean (n = 20) = 532.1 +/- 54.17 g
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
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