Registration Dossier
Registration Dossier
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EC number: 202-216-2 | CAS number: 93-08-3
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 publication
Data source
Reference
- Reference Type:
- publication
- Title:
- skin sensitization potential of test chemical
- Author:
- D. L. J. Opdyke
- Year:
- 1 975
- Bibliographic source:
- Food and Cosmetics Toxicology,1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine skin sensitization potential of test chemical in human using maximization test
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Human Maximization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD
Test material
- Reference substance name:
- 2'-acetonaphthone
- EC Number:
- 202-216-2
- EC Name:
- 2'-acetonaphthone
- Cas Number:
- 93-08-3
- Molecular formula:
- C12H10O
- IUPAC Name:
- 1-(naphthalen-2-yl)ethan-1-one
- Details on test material:
- - Name of test material (as cited in study report): 2'-acetonaphthone
- 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: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- Adequacy of induction:
- other: no skin sensitization reactions
Challenge
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2 %
- Adequacy of challenge:
- other: no skin sensitization reactions
- No. of animals per dose:
- 25
- Details on study design:
- no data
- Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- other: no sensitization reactions.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- Since the test chemical did not cause any known signs of contact sensitization, it was considered as not sensitizing to human skin.
- Executive summary:
Maximization test was performed in 25 human subjects to assess the skin sensitization potential of test chemical. The test chemical was applied dermally to the skin of human volunteers at a dose of 2% in petrolatum. Since the test chemical did not cause any known signs of contact sensitization, it was considered as not sensitizing to human skin.
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