Registration Dossier
Registration Dossier
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EC number: 216-133-4 | CAS number: 1506-02-1
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 18 June 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The report is a historical overview of the conditions of workers with regard to respiratory sensitisation.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Principles of method if other than guideline:
- The olfactive quality control of Tonalid is a repeated exposure to Tonalid. The history of the staff of quality assurance has been reviewed. No specific test protocol has been developed prior to the assessment. However, the olfactive quality control procedure at the Quality Assurance (QA) department of PFW Aroma Chemicals BV has been described in detail as part of the ISO 9001 certification. PFW has been ISO 9001 certified and keeps record of the olfactive quality control.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- EC Number:
- 216-133-4
- EC Name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
- Cas Number:
- 1506-02-1
- Molecular formula:
- C18H26O
- IUPAC Name:
- 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one
Constituent 1
Test animals
- Species:
- human
- Sex:
- male/female
Test system
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 100% AHTN
- Details on study design:
- Workers at the quality assurance department conduct olfactive quality controls of pure (100%) AHTN (CAS 1506-02-1). Liquid samples, which are at elevated temperatures are cooled, solidified and ground. Powder samples are only ground. Olfactive control takes place at the head space of the sample.
Results and discussion
- Results:
- No sensory irritation of the airways and no respiratory reactions like asthma, rhinitis and alveolites were reported over a period of more than two decades.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- and not a respiratory irritant
- Conclusions:
- Based on the human practical experience, it is concluded that AHTN is not a respiratory irritant or sensitiser.
- Executive summary:
Respiratory irritation and sensitisation have been assessed on the basis of occupational exposure of the quality assurance staff to pure AHTN during the olfactive quality control of Tonalid.
No adverse respiratory responses to AHTN have been reported. It is concluded that AHTN is not a respiratory irritant or sensitiser.
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