Registration Dossier
Registration Dossier
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EC number: 217-316-1 | CAS number: 1809-19-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: Report on medical surveillance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Human exposure on specific chemicals. Even if not GLP the reliability of the study is very high.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- Type of sensitisation studied:
- respiratory
- skin
- Study type:
- other: medical surveillance at manufacturing site
- GLP compliance:
- no
Test material
- Reference substance name:
- Dibutyl phosphonate
- EC Number:
- 217-316-1
- EC Name:
- Dibutyl phosphonate
- Cas Number:
- 1809-19-4
- Molecular formula:
- C8H19O3P
- IUPAC Name:
- dibutyl phosphonate
- Test material form:
- liquid
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not applicable
- Subjects:
- - Number of subjects exposed: 15 per year; 12 have been employed since 2008
- Sex: male/female
- Age: occupational life span - Clinical history:
- All workers are routinely controlled once in a year and in case of accidents.
- Controls:
- Yearly
- Route of administration:
- other: Dermal and inhalation
- Details on study design:
- Manufacturing is in batch in closed system. Exposure may occur during discharge and maintenance.
Results and discussion
- Results of examinations:
- No sign of sensitisation has ever been detected.
Applicant's summary and conclusion
- Conclusions:
- No workers have ever experienced sensitisation to the substance.
- Executive summary:
The substance has been manufactured since 2008 on three rolls composed by 4 workers each. On a daily basis, 12 workers are exposed to the substance during discharge and maintenance. In total 15 workers may be in contact with the substance. Among those, 12 have been employed since 2008 and working in the manufacturing of the substance.
No workers have ever experienced sensitisation to the substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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