Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Study type:
health record from industry
Endpoint addressed:
not applicable
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In accordance with the Dow Chemical Company Ltd and DowElanco Ltd occupational health policy and guidelines a specific health surveillance programme was undertaken with regard to the manufacture and packaging of Fluroxypyr in the United Kingdom (IIA 5.9.1/01). Base line medical examinations occurred before the start of production in 1984 at the King's Lynn site in the United Kingdom and during the first year of manufacture a six monthly review of general non-specific haematological and biochemical parameters were undertaken with specific attention to liver and kidney function. In addition, bi monthly urine examination was conducted for urinary fluoride estimation as the manufacturing process involves the use of ammonium fluoride and by product production of sodium fluoride. A register was also kept of all complaints and occurrences as was a record of concurrent exposure to other chemicals and reagents.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Methylheptyl, 0-(4-amino-3,5-dichloro-6-fluoro-2-pyridyloxy) acetate
IUPAC Name:
Methylheptyl, 0-(4-amino-3,5-dichloro-6-fluoro-2-pyridyloxy) acetate
Constituent 2
Reference substance name:
1-methylheptyl [(4-amino-3,5-dichloro-6-fluoropyridin-2-yl)oxy]acetate
EC Number:
279-752-9
EC Name:
1-methylheptyl [(4-amino-3,5-dichloro-6-fluoropyridin-2-yl)oxy]acetate
Cas Number:
81406-37-3
IUPAC Name:
1-methylheptyl [(4-amino-3,5-dichloro-6-fluoropyridin-2-yl)oxy]acetate
Constituent 3
Reference substance name:
Acetic acid [(4-amino-3,5-dichloro-6-fluoro-2-pyridinyl) oxy], 1-methylheptyl
IUPAC Name:
Acetic acid [(4-amino-3,5-dichloro-6-fluoro-2-pyridinyl) oxy], 1-methylheptyl
Details on test material:
no details available, human health surveilance data

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
Information was also specifically sought on sensitisation and allergic response to the active and there have been no positive reports.
Analysis of all the collected health data since start of manufacture in 1984 using both group data and individual employee data has not revealed any significant acute or chronic medical abnormality. This includes the examination of all haematological and biochemical parameters and data from physical examination, including lung function studies and skin examination.

Results and discussion

Results:
Information was also specifically sought on sensitisation and allergic response to the active and there have been no positive reports.
Analysis of all the collected health data since start of manufacture in 1984 using both group data and individual employee data has not revealed any significant acute or chronic medical abnormality. This includes the examination of all haematological and biochemical parameters and data from physical examination, including lung function studies and skin examination.

Applicant's summary and conclusion