Registration Dossier
Registration Dossier
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EC number: 217-752-2 | CAS number: 1948-33-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Skin sensitization study was conducted to determine the skin sensitization potential of test chemical.
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2-tert-butylhydroquinone
- EC Number:
- 217-752-2
- EC Name:
- 2-tert-butylhydroquinone
- Cas Number:
- 1948-33-0
- Molecular formula:
- C10-H14-O2
- IUPAC Name:
- 2-tert-butylbenzene-1,4-diol
- Details on test material:
- - Name of test material: 2-tert-butylhydroquinone
- Molecular formula: C10H14O2
- Molecular weight: 166.22
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: not specified
- Vehicle:
- other: A+D+GP Fat
- Concentration / amount:
- 500mg (0.5g) in 5 mL A+D+GP Fat
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: not specified
- Vehicle:
- other: A+D+GP Fat
- Concentration / amount:
- 1000mg (1.0g) in 10 mL A+D+GP Fat
- Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Not specified
- Details on study design:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1000 mg (1.00g) in 10 mL A+D+GP Fat
- Clinical observations:
- Moderate risk for human sensitization
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
SUMMARY |
||||||
|
HIGHEST AVERAGE |
CONC. FOR CHALLENGE |
||||
Drop on |
0 |
1.00 g IN 10mL A+D+GP Fat |
||||
|
NUMBER POSITIVE |
TOTAL SCORE |
||||
Sensitization |
NORMAL |
SLIGHT |
MODERATE |
SEVERE |
|
|
Freund’s only |
10 |
|
|
|
0 |
|
1% cpd in Freunds |
1 |
1 |
8 |
|
41 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: sensitising
- Conclusions:
- The test substance showed moderate risk for human skin sensitization.
- Executive summary:
The skin sensitization study was conducted on human subjects to assess the skin sensitization potential of test chemical.
The subjects were treated at dose of 500 mg in 5 ml A+D+GP Fat during induction and challenged at concentration 1000mg in 10 ml A+D+GP Fat.
The test chemical induced moderate skin sensitization at tested concentrations. Hence the test material was considered to be sensitizing to the skin of human subjects.
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