Registration Dossier
Registration Dossier
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EC number: 262-975-0 | CAS number: 61788-44-1
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peerreivewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment
- Author:
- Mary Ann Liehert
- Year:
- 1 984
- Bibliographic source:
- International Journal of Toxicology; 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below.
- Principles of method if other than guideline:
- To evaluate the skin sensitizing potential of test chemical l in human by patch test.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- tert-butyl-4-methoxyphenol
- EC Number:
- 246-563-8
- EC Name:
- tert-butyl-4-methoxyphenol
- Cas Number:
- 25013-16-5
- Molecular formula:
- C11H16O2
- IUPAC Name:
- (1,1-Dimethylethyl)-4-methoxyphenol
- Details on test material:
- Name: Butylated Hydroxyanisole
Molecular Formula: C11H16O2
Molecular Weight: 181.253 g/mole
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- No data available.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.2 %
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.2%
- Day(s)/duration:
- 24 hour
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 108 adult panelists (70 females, 38 males)
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hour
- Test groups: yes
- Control group: No data available
- Site: upper arm
- Frequency of applications: every other day for continuous 3 weeks
- Duration: 3 weeks
- Concentrations: 0.2%
B. CHALLENGE EXPOSURE
- No. of exposures:Single
- Day(s) of challenge: 2 weeks
- Exposure period: 24 hour
- Test groups: Yes
- Control group: No data available
- Site: No data available
- Concentrations: 0.2%
- Evaluation (hr after challenge): 24 hour
OTHER: - Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2%
- No. with + reactions:
- 0
- Total no. in group:
- 108
- Clinical observations:
- No sensitization observed.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No sensitization observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical at a concentration of 0.2 % was tested in 108 adult panelists by 24-hour in occlusive patch test .No sensitization observed . Hence the test chemical was considered to be non-sensitizing in any 108 panelists.
- Executive summary:
A skin sensitization test was observed in 108 (70 females, 38 males) to determine their skin response to a cream containing 0.2 percent test chemical. The method used was a modification of the repeated insult patch test. A 24-hour occlusive patch to the upper arm was applied every other day for 3 weeks (nine induction applications), a 2-week rest, followed by a 24-hour occlusive challenge patch. After the challenge exposure no sensitization was observed in any subject. Therefore the test chemical was considered to be non-sensitizing to human skin.
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