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EC number: 407-920-5 | CAS number: 6390-69-8 CA 16-178
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- Remarks:
- no positive control group included, but the sensitivity of the strain is checked every six months in the testing facility with Paraphenylene-diamine or Potassium-dichromate.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol
- EC Number:
- 407-920-5
- EC Name:
- 3,3',5,5'-tetra-tert-butylbiphenyl-2,2'-diol
- Cas Number:
- 6390-69-8
- Molecular formula:
- C28 H42 O2
- IUPAC Name:
- 3,3',5,5'-tetra-tert-butyl-[1,1'-biphenyl]-2,2'-diol
- Details on test material:
- - Name of test material (as cited in study report): generic name CA 16-178
- Physical state: yellowish powder
- Analytical purity: 97.7% (not specified in the study [Lab. sample], transfered from 28d study [BASF SE [Ciba-Geigy Ltd/884619]], with same Lot/batch)
- Lot/batch No.: A 88103 / Z 1572R
- Storage condition of test material: room temperature
- Other: gloves and face masks as safety precautions
Constituent 1
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: Pirbright White Strain (Tif: DHP) from Animal production, CIBA-GEIGY Limited, 4332 Stein/Switzerland
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 324 - 427 g
- Housing: individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG No. 845, Gossau SG; ad libitum
- Water (e.g. ad libitum): fresh drinking water; ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil (intradermal injection) or vaseline (soft white petrolatum; epidermal application)
- Concentration / amount:
- 1% at intradermal induction, 30% at epidermal induction and 10% at epidermal challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil (intradermal injection) or vaseline (soft white petrolatum; epidermal application)
- Concentration / amount:
- 1% at intradermal induction, 30% at epidermal induction and 10% at epidermal challenge
- No. of animals per dose:
- 10 per sex per group
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal application (induction): the concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles (concentration: 1%; vehicle: sesame oil).
- Epidermal application (induction): the concentration for the epidermal application was selected on account of the primary irritation potential of the test substance (concentration: 30%; vehicle: Vaseline).
- Epidermal application (challenge): the concentration for the epidermal application was selected on account of the primary irritation potential of the test substance (concentration: 30%; vehicle: Vaseline)
- The following concentrations have been examined on separate animals for the evaluation of the primary irritant potential and the maximum subirritant concentration of the test substance: 10 and 30 % in Vaseline. The tested concentrations did not induce erythema reactions. 30% was, therefore, selected for the epidermal induction application. 10% was used as subirritant concentration for the challenge application, because highest concentrations may lead to nonspecific reactions in adjuvant treated animals
MAIN STUDY
A. INTRADERMLA INDUCTION EXPOSURE
- No. of exposures: 1 (3 pair of intradermal injections, 0.1 ml per injection)
- Exposure period: day 1
- Test groups: 3 injections of (1) adjuvant and saline (1:1), (2) test substance in sesame oil, and (3) test substance in the adjuvant saline mixture
- Control group: same as test group, without test substance
- Site: into the shaved neck
- Frequency of applications: once
- Duration: one injection
- Concentrations: 1% test substance in sesame oil
B. EPIDERMAL INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: one week after the intradermal injection
- Test groups: test substance incorporated in Vaseline (patch 2x4 cm; approx. 0.4 g paste per patch)
- Control group: Vaseline alone
- Site: over the injection sites; the application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application).
- Frequency of applications: once
- Duration: 48 hours occluded application
- Concentrations: 30% test substance in Vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 2 weeks after epidermal induction
- Test groups: test substance incorporated in Vaseline (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration)
- Control group: Vaseline alone
- Site: on the flank
- Concentrations: 10% test substance in Vaseline
- Evaluation (hr after challenge): 24 hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours thereafter.
OTHER:
- After the intradermal and the epidermal induction application, irritant reactions are normally induced by the adjuvant, the high test article concentration, or the sodium lauryl sulfate pretreatment. Because most of the reactions are treatment related and not compound related, the reactions are only described in special cases.
- The body weight was recorded at start and end of the test. - Challenge controls:
- None
- Positive control substance(s):
- no
- Remarks:
- the sensitivity of the strain is checked successfully in the testing facility every six months with Paraphenylene-diamine or Potassium-dichromate.
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked successfully in the testing facility every six months with Paraphenylene-diamine or Potassium-dichromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (vehicle at induction and at challenge)
- 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: 0% (vehicle at induction and at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (vehicle at induction and at challenge)
- 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: 0% (vehicle at induction and at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% (vehicle at induction and test substance at challenge)
- 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: 10% (vehicle at induction and test substance at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% (vehicle at induction and test substance at challenge)
- 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: 10% (vehicle at induction and test substance at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0% (test substance at induction and vehicle at challenge)
- 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: 0% (test substance at induction and vehicle at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0% (test substance at induction and vehicle at challenge)
- 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: 0% (test substance at induction and vehicle at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (test substance at induction and test substance at challenge)
- 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: 10% (test substance at induction and test substance at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (test substance at induction and test substance at challenge)
- 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: 10% (test substance at induction and test substance at challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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