Registration Dossier
Registration Dossier
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EC number: 203-139-7 | CAS number: 103-73-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- other: Authoritative database
- Title:
- determination of Skin sensitization for the test chemical
- Author:
- HSDB
- Year:
- 2 018
- Bibliographic source:
- U.S. National Library of Medicine National Institutes of Health, Health & Human Services; 2017.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A human maximization test was conducted for the test chemical to assess the potential of contact allergy caused by the chemical under occlusive condition.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- phenoxybenzene
- Cas Number:
- 101-84-8
- Molecular formula:
- C12H10O
- IUPAC Name:
- phenoxybenzene
- Test material form:
- liquid
- Details on test material:
- - Name of test material: Diphenyl ether
- Molecular formula: C12H10O
- Molecular weight: 170.211 g/mol
- Substance type: Organic
- Physical state: Liquid
- Smiles: c1(Oc2ccccc2)ccccc1
-InChI:1S/C12H10O/c1-3-7-11(8-4-1)13-12-9-5-2-6-10-12/h1-10H
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- 5 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- No data available
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: no data
- Control group: no data
- Site: same forearm sites
- Frequency of applications: five alternate-day 48-hour periods
- Duration: 5 days
- Concentrations: 4%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 10 days
- Exposure period: 48 hours
- Test groups: no data
- Control group: no data
- Site: fresh sites on the scapular backs
- Concentrations: 4%
- Evaluation (hr after challenge): 48 and 72 hours - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Clinical observations:
- Diphenyl oxide did not produce any cases of contact allergy.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Diphenyl oxide did not produce any cases of contact allergy.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical failed to induce any signs of dermal sensitization after 72 hours of observation. Hence, the test chemical can be considered to be not sensitizing to skin.
- Executive summary:
A human maximization test was conducted to assess the potential of contact allergy caused by the chemical under occlusive condition.
The test material was mixed into petrolatum N.F. at 4% concentration and applied to the same forearm sites under occlusion for five alternate-day 48-hour periods. Each application of the test material was preceded by treatment of the patch site with 5% aqueous sodium lauryl sulfate under occlusion.
Following a ten day rest period challenge patches of the test material were applied to fresh sites on the scapular backs under occlusion for 48 hours. The challenge sites were pretreated for one hour with 10% aqueous sodium lauryl sulfate. Clinical evaluations were made at 48 and 72 hours.
The test material was considered to be not sensitizing to the human skin in human maximization test.
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