Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: This study is considered not reliable as only one test animal was used for studying the organ distribution as well as the excretion. Thus there are significant methodological deficiences and the study is rated Klimisch 3b.

Data source

Reference
Reference Type:
publication
Title:
Adhesion of synthetic organic polymer to soft tissue IV. Evualtion of a silicone adhesive system
Author:
Wang P.Y. and Ewans D.W.
Year:
1977
Bibliographic source:
Biomat., Med. Dev., Art. Org.; 5(3): 277-291

Materials and methods

Objective of study:
distribution
excretion
Principles of method if other than guideline:
Labelled benzoyl chloride was applied over a 3 cm² area on the dorsal musculature of two male Wistar rat through a small incision. Of one of these rats urine and feces was collected during a 15 day period. The major internal organs of the other rat were isolated after 3 days.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): benzoyl chloride
- Specific activity (if radiolabelling): 3µc/µL
- Locations of the label (if radiolabelling): 14C-carboxyl labelled benzoyl chloride
- Other:
radio-active benzoyl was separated by distillation, further purified and sterilized after preparation
Radiolabelling:
yes
Remarks:
14C-carboxyl labelling

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
Organ distribution: One application, maesurement after 3 days
Excretion: One application and measurements over 15 day period
Doses / concentrations
Remarks:
Doses / Concentrations:
10 µL
No. of animals per sex per dose:
Organ distribution: 1
Excretion: 1
Control animals:
yes

Results and discussion

Preliminary studies:
No data

Toxicokinetic / pharmacokinetic studies

Details on absorption:
No data
Details on distribution in tissues:
Heart < brain < kidneys < spleen < liver < lungs < skin/muscle
Details on excretion:
Only a very small amount of radioactivity was found in the urine and feces measured over a period of 15 d.

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no data
The authors tested the distribution in organs and the excretion via urine and feces of benzoyl chloride. Labelled benzoyl chloride was applied over a 3 cm² area on the dorsal musculature of two male Wistar rats through a small incision. Of one of these rats urine and feces was collected during a 15 day period., while the major internal organs of the other rat were isolated after 3 days. In these test conditions only a very small amount of radioactivity was found in the urine and feces measured over a period of 15 d. The distribution of benzoyl chloride was as follows: heart < brain < kidneys < spleen < liver < lungs < skin/muscle.
Executive summary:

The authors tested the distribution in organs and the excretion via urine and feces of benzoyl chloride (CAS n° 98-88-4). Labelled benzoyl chloride (10µL, specific activity 3 µc/µL) was applied over a 3 cm² area on the dorsal musculature of two male Wistar rats through a small incision. Of one of these rats urine and feces was collected during a 15 day period., while the major internal organs of the other rat were isolated 3 days after application. In these test conditions only a very small amount of radioactivity was found in the urine and feces measured over a period of 15 d. Furthermore, the distribution of benzoyl chloride was as follows: heart < brain < kidneys < spleen < liver < lungs < skin/muscle.

No data is available on the GLP status of this study. Moreover, this study is considered not reliable as only one test animal was used for studying the organ distribution as well as the excretion via urine and feces. Hence there are significant methodological deficiences and the study is rated Klimisch 3b.