Registration Dossier
Registration Dossier
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EC number: 201-993-5 | CAS number: 90-43-7
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
- Study period:
- 1984/1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP guideline study with some deviations from current guideline
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Contact allergy to chlorocresol, formaldehyde and other biocides.
- Author:
- Andersen, K.E.
- Year:
- 1 986
- Bibliographic source:
- Acta Dermato-Verereologica, Supplementum 125, pp. 2-21.
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
- Reference Type:
- secondary source
- Title:
- O-Phenylphenol and its Sodium and Potassium Salts: A Toxicological Assessment
- Author:
- Bomhard, E. M. et al.
- Year:
- 2 002
- Bibliographic source:
- Crit. Rev. Toxicol. 32(6):551-626
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- some reporting deficits, no appropriate positive control
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No. 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Test material
- Reference substance name:
- Biphenyl-2-ol
- EC Number:
- 201-993-5
- EC Name:
- Biphenyl-2-ol
- Cas Number:
- 90-43-7
- Molecular formula:
- C12H10O
- IUPAC Name:
- [1,1'-biphenyl]-2-ol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Preventol o extra, Dowicide I, o-phenylphenol
- Physical state: white granules
- Analytical purity: > 99.5%
- Other: information presented is as given from supplier
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: outbred albino guinea pigs (Ssc: Al)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Statens Seruminstitute
- Weight at study initiation: 350-450 g
- Housing: in plastic cages
- Diet: standard diet, ad libitum
- Water: with vitamin C enriched, ad libitum
- Acclimation period: 1 week
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: propylene glycol (PG) for the intradermal induction; for induction and challenge patch tests yellow petroleum was used
- Concentration / amount:
- 1st application: Induction 0.5 or 5 % intradermal injection
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 5 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: propylene glycol (PG) for the intradermal induction; for induction and challenge patch tests yellow petroleum was used
- Concentration / amount:
- 1st application: Induction 0.5 or 5 % intradermal injection
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Challenge 5 % occlusive epicutaneous
- No. of animals per dose:
- 20 for both control and test groups
- Details on study design:
- RANGE FINDING TESTS:
The concentration used for induction and challenge were determined in a minimum of 4 guinea pigs. For these one application irritancy tests animals were treated with FCA/vehicle (1:1) intradermal injections in the postnuchal area 3-5 weeks prior to the irritancy test. For intradermal and topical induction, a moderately irritant concentration was chosen. For challenge a non-irritant concentration and dilutions thereof were used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Test groups:
Intradermal injection: FCA was emulsified with vehicle or test material (1:1 v/v) (not further specified)
Epicutaneous induction: 0.5 mL test material on filter paper mounted on Leucoflex sealed with Acrylastic
- Control group:
The control animals were treated as the test animals but with the vehicle only (not further specified)
- Concentrations: 0.5 or 5% intradermal injections; 25% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 48 h
- Test groups: 0.5 mL test material in Finn Chambers on Scanpor sealed with Acrylastic.
- Control group: The control animals were treated as the test animals (not further specified)
- Site: flanks
- Concentrations: 5%
- Evaluation (hr after challenge): 48 h
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: test group induced with 0.5% intradermal injection annd 25% epicutaneous application
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: test group induced with 0.5% intradermal injection annd 25% epicutaneous application. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: test group induced with 5% intradermal injection annd 25% epicutaneous application
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: test group induced with 5% intradermal injection annd 25% epicutaneous application. Dose level: 5% . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% for induction; 5% epicutaneous treatment for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- other: not included in this study
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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