Registration Dossier

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:
2010

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
Name:
Unnamed
Type:
Constituent

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.