Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is sufficiently documented, meets generally accepted scientific principles and is acceptable for assesment, thus klimisch 2e

Data source

Reference
Reference Type:
publication
Title:
Über das Auftreten von Krebs bei Mäusen nach Inhalation von Benzotrichlorid und Benzoylchlorid
Author:
Yoshimura H., Takemoto K.; Fukuda K. and Matsushita H.
Year:
1986
Bibliographic source:
Japanese Journal of Industrial health, 28: 352-359

Materials and methods

Principles of method if other than guideline:
Carcinogenicity induced by repeated inhalation
(For details on methodology see section examinations)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): BC (benzoylchlorid)

No more data available

Test animals

Species:
mouse
Strain:
ICR
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
5 months
Frequency of treatment:
twice weekly for 30 minutes
No. of animals per sex per dose:
30 (28 were evaluated)
Control animals:
yes

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

- Cutaneous lesions:

At the end of exposure hair-loss and inflammation was observed.

- Gross pathology:

At necropsy many animals showed inflammation of the lymp nodes, liver and spleen.

Mild keratosis and hyperplasia of the gastric mucosa was seen.

No malignant lymphoma was noted.

Applicant's summary and conclusion

Conclusions:
The authors tested the toxicity of benzoyl chloride after repeated dose exposure via inhalation of vaporized test substance. Only cutaneous lesions were observed, no pulmonary. The gross pathology of animals showed inflammation of the lymp nodes, liver and spleen. Also mild keratosis and hyperplasia of the gastric mucosa was seen. On the other hand no malignant lymphoma were noted.
Executive summary:

The authors tested the toxicity of benzoyl chloride (CAS n° 98-88-4)after repeated dose exposure via inhalation of vaporized test substance. Thirty ICR male mice were exposed to benzoyl chloride vaporized at 50°C twice weekly for 30 minutes during 5 months. Afterwards they were observed for another 9 months. Pathological changes in the respiratory system and skin were noted as well as mortality and gross pathology.

At the end of exposure hair-loss and inflammation was observed. At necropsy, many animals showed inflammation of the lymp nodes, liver and spleen. Also mild keratosis and hyperplasia of the gastric mucosa was seen. Finally no malignant lymphoma were noted.

 

The GLP status of the study is unknown. Although the study would benefit from a more elaborate description of clinical signs, gross pathology and weight development, it is nevertheless sufficiently documented, meets generally accepted scientific principles and is acceptable for assessment. Thus the study is reliable with restrictions, Klimisch 2e.