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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2003

Materials and methods

Study type:
other: biological monitoring
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
other: biological monitoring of 4-ADPA
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(4-aminophenyl)aniline
EC Number:
202-951-9
EC Name:
N-(4-aminophenyl)aniline
Cas Number:
101-54-2
Molecular formula:
C12H12N2
IUPAC Name:
N1-phenylbenzene-1,4-diamine
Details on test material:
no data

Method

Subjects:
- Number of subjects exposed: 669
Route of exposure:
other: occupational
Reason of exposure:
other: occupational

Results and discussion

Clinical signs:
Measurment: 4 -ADPA-adducts in blood (4 -ADPA-hemoglobin-adducts) (µg/l), free and total 4 -ADPA in urine (µg/l)

Any other information on results incl. tables

In the frame of the occupational surveillance program the levels of 4-ADPA-adducts in blood and of 4-ADPA in urine are measured at least once a year in each worker of a 4-ADPA manufacturing plants. In the previous years, e.g. 2202, the measured results were below the detection limits.

Applicant's summary and conclusion