Registration Dossier
Registration Dossier
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EC number: 210-296-5 | CAS number: 612-16-8
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:
- A toxicological and dermatological assessment of aryl alkyl alcohols when used as fragrance ingredients.
- Author:
- D. Belsito, D. Bickers, M. Bruze, P. Calow, M.L. Dagli, A.D. Fryer, H. Greim, Y. Miyachi, J.H. Saurat , I.G. Sipes
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology, Vol. 50, Pg. no. S52-S99, 2012.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A human repeated insult patch test (HRIPT) was conducted on 39 volunteers to assess the contact sensitization potential of chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8).
- GLP compliance:
- not specified
- Type of study:
- other: Human Repeated Insult Patch Test (HRIPT)
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2-methoxybenzyl alcohol
- EC Number:
- 210-296-5
- EC Name:
- 2-methoxybenzyl alcohol
- Cas Number:
- 612-16-8
- Molecular formula:
- C8H10O2
- IUPAC Name:
- (2-methoxyphenyl)methanol
- Test material form:
- liquid
- Details on test material:
- - Name of test material : (2-methoxyphenyl)methanol
- Common name : 2-Methoxybenzyl alcohol
- Molecular formula : C8H10O2
- Molecular weight : 138.165 g/mol
- Smiles notation : O(c1c(cccc1)CO)C
- InChl : 1S/C8H10O2/c1-10-8-5-3-2-4-7(8)6-9/h2-5,9H,6H2,1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Methoxybenzyl alcohol
- Molecular formula: C8H10O2
- Molecular weight: 138.165 g/mol
- Substance type: Organic
- Physical state: liquid
-Smiles: O(c1c(cccc1)CO)C
-InChI: 1S/C8H10O2/c1-10-8-5-3-2-4-7(8)6-9/h2-5,9H,6H2,1H3
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethyl alcohol (EtOH)
- Concentration / amount:
- 1.2%
- Day(s)/duration:
- 3 Weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethyl alcohol (EtOH)
- Concentration / amount:
- 1.2%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 39 subjects
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
- Test groups: 39 subjects
- Control group: no data
- Site: no data
- Frequency of applications: 3 times/week
- Duration: 3 weeks
- Concentrations: 1.2%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: 24 hours
- Test groups: 39 subjects
- Control group: no data
- Site: no data
- Concentrations: 1.2%
- Evaluation (hr after challenge): after24 hours - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.2%
- No. with + reactions:
- 0
- Total no. in group:
- 39
- Clinical observations:
- None of the volunteers showed any signs of contact sensitization.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- None of the volunteers showed any signs of contact sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- None of the volunteers had showed any signs of skin sensitization. Hence the chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8) was considered to be not sensitizing to the skin of human subjects.
- Executive summary:
A human repeated insult patch test (HRIPT) was conducted on 39 volunteers to assess the contact sensitization potential of chemical 2-Methoxybenzyl alcohol (CAS no: 612-16-8).
Each subject was induced with1.2% of2-Methoxybenzyl alcohol inEtOH three times per week for 3 weeks under occlusive condition. After induction, all the treated subjects were challenged at same concentration used in induction and later observed for skin reactions after 24 hours.
None of the volunteers showed any signs of skin sensitization. Hence the chemical2-Methoxybenzyl alcohol (CAS no: 612-16-8) was considered to be not sensitizing to the skin of human subjects.
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