Registration Dossier
Registration Dossier
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EC number: 204-442-7 | CAS number: 121-00-6
Skin sensitisation
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Butylated Hydroxyanisole
- Author:
- Journal of Toxicology
- Year:
- 1 984
- Bibliographic source:
- International Journal of Toxicology; Volume 3, Issue 5; page 83-146, 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The modified repeated insult patch test described by Draize was conducted to assess the skin sensitization potential of test chemical.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material: tert-butyl-4-methoxyphenol
- Common name: Phenol, (1,1-dimethylethyl)-4-methoxy-
- Molecular formula: C11H16O2
- Molecular weight: 180.2454 g/mol
- Smiles notation: COc1ccc(O)c(c1)C(C)(C)C
- InChI=1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
- Substance type: Organic
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: Not applicable
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Cream
- Concentration / amount:
- 0.2 %
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Cream
- Concentration / amount:
- 0.2%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 108 adult panelists (70 females, 38 males)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
- Test groups: 108
- Control group: not specified
- Site:upper arm
- Frequency of applications: every other day for 3 weeks (nine induction applications)
- Duration: 3weeks
- Concentrations: 0.2%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 week rest
- Exposure period: 24 hours
- Test groups: 108
- Control group: no data
- Site: no data
- Concentrations: 0.2%
- Evaluation (hr after challenge): after 24 hours - Challenge controls:
- Not specified
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2%
- No. with + reactions:
- 108
- Total no. in group:
- 0
- Clinical observations:
- No skin sensitization was observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The test chemical at a concentration of 0.02 % in 108 adult panelists for 24-hour in occlusive patch test was considered to be non-sensitizing.
- Executive summary:
The modified repeated insult patch test described by Draize was conducted to assess the skin sensitization potential of test chemical. During induction, one hundred eight adult panelists (70 females, 38 males) were tested to determine their skin response to a cream containing 0.2 percent of test chemical. The procedure called for a 24hour occlusive patch to the upper arm every other day for 3 weeks (nine induction applications), a 2-week rest, followed by a 24hour occlusive challenge patch. Since there were no evidence of any contact allergic reaction, the test chemical was considered to be not- sensitizing to the skin of treated panelist.
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