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Toxicological information

Skin sensitisation

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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:
1984
Bibliographic source:
International Journal of Toxicology; Volume 3, Issue 5; page 83-146, 1984

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): tert-butyl-4-methoxyphenol
- Substance type: Organic
- Physical state: Solid

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

Study design: in vivo (LLNA)

Vehicle:
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin sensitization was observed.

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.