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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
basic toxicokinetics
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method

Data source

Reference
Reference Type:
other: Weight of evidence
Title:
Toxicokinetics
Author:
Sustainability Support Services (Europe) AB
Year:
2012
Bibliographic source:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Based on the weight of evidence of various phys chem and bioaccumulative parameters in the dossier
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-acetylsulphanilyl chloride
EC Number:
204-485-1
EC Name:
N-acetylsulphanilyl chloride
Cas Number:
121-60-8
Molecular formula:
C8H8ClNO3S
IUPAC Name:
4-acetamidobenzenesulfonyl chloride
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): N-acetylsulphanilyl chloride
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
other: unspecified
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: estimation
Vehicle:
unchanged (no vehicle)
Control animals:
not specified

Results and discussion

Preliminary studies:
Based on the results of dermal toxicokinetics it can be stated that the substance will have low absorption capability similar to as shown in dermal absorption, according to which the Danish (Q)SAR dermal absorption of N-acetyl sulphanilyl chloride is 0.00200 (Low).This value indicates low dermal absorption.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The Danish EPA database indicates the dermal absorption potential of N-acetylsulphanilyl chloride to be low (0.00200 mg/cm2/event). Also considering the particle size of the chemical as well as the low vapour pressure (0.0000446 Pa at 25°C), absorption by the inhalation route is expected to be low. There is a possibility of absorption by the gastro-intestinal tract upon oral intake of the chemical; as part of the sulpha drugs. The chemical is known to be moderately toxic by ingestion, if administered in high dose levels
Details on distribution in tissues:
There are reports that suggest decomposition of N-acetylsulphanilyl chloride in water. Considering the high solubility of the chemical N-acetylsulphanilyl chloride in organic solvents, the chemical is likely to be distributed in the lipid fraction of the living system.
Details on excretion:
The bio-concentration factor of -acetylsulphanilyl chloride is very low and ranges between the value 8.06 – 14.79. Also, the Log Kow value is < 3. These facts suggests that the chemical is unlikely to bio-accumulate within the living system after absorption and distribution. Normally the chemicals that do not bio-accumulate within the living systems are rapidly eliminated either through the urine, bile or faeces. Fat soluble (organic medium) chemicals may be conjugated and excreted in bile (faeces).

Metabolite characterisation studies

Details on metabolites:
There are no details available on the possible metabolites of the chemical N-acetylsulphanilyl chloride.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: low bioaccumulation potential based on study results
In case the substance,N-acetyl sulphanilyl chloride, is absorbed (though in small quantity) it will not be accumulated in the body. This is supported by the fact that the substance have not only low BCF value but alos have a moderate level of Kow which will support the reasoning that though the substance will enter the body but will get distributed through the lipid in the body.
Executive summary:

Based upon the physico-chemical properties of N-acetylsulphanilyl chloride, and comparing then with the general toxico-kinetic features; it can be predicted that the bio-accumulation potential of the chemical is expected to be low.