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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: 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

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 (if applicable):
not specified
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
5 months
Frequency of treatment:
twice weekly for 30 minutes
Post exposure period:
9 months
No. of animals per sex per dose:
30 (28 were evaluated)
Control animals:
yes

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:
No significant increase in incidence of pulmonary tumors or skin tumors was observed in mice exposed to vapourized benzoyl chloride compared to controls

Any other information on results incl. tables

- Table: Tumor incidence in mice by inhalation of benzoyl chloride vaporized at 50°C

Period (month)

Number of mice

Number of lung tumor (%)

Number of skin tumor (%)

2-6

8

0

0

-10

13

0

2 (15.4)

-14

7

3 (42.9)

0

Total

28

3 (10.7)

2 (7.1)

- Results in detail:

All 8 treated mice that died during the exposure period did not have tumors. Between the end of exposure (5 months) and month 10, 2/13 mice had developed skin papillomas. From month 10 till the end of the experiment 1/7 mice had lung adenomas, 2/7 had lung adenocarcinoma. Thus the overall tumour incidence was 3/28 (10.7%) for the lung and 2/28 (7.1%) for the skin.

In the control 3/30 (10%) mice developed lung adenomas during the 12 months observation period and no other tumors were observed.

No significant increase in the incidence of pulmonary tumors and skin tumors was observed in the treated animals in comparison to the control.

- Pathological changes in the skin:

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

Applicant's summary and conclusion

Conclusions:
The authors tested the carcinogenicity of benzoyl chloride through inhalation of vapourized test substance. The authors observed no significant increase in the incidence of pulmonary tumors and skin tumors in comparison to the controls. Hence, benzoyl chloride is non carcinogenic.
Executive summary:

The authors tested the carcinogenicity of benzoyl chloride (CAS n° 98-88-4) through inhalation by exposing ICR male mice to benzoyl chloride vapour. A total of 30 mice were exposed to benzoyl chloride vapourized at 50°C twice weekly for 30 minutes during 5 months. Afterwards they were observed for another 9 months. Furthermore pathological changes in the respiratory system and skin were noted.

Eight treated mice died during the exposure period and none of them had tumors. Between the end of exposure (5 months) and month 10, 2/13 mice had developed skin papillomas. From month 10 till the end of the experiment 1/7 mice had lung adenomas and 2/7 had lung adenocarcinoma. Thus the overall tumour incidence was 3/28 (10.7%) for the lung and 2/28 (7.1%) for the skin for the treated mice. Furthermore, at the end of exposure hair-loss and inflammation was observed in the treated mice.

In the control 3/30 (10%) mice developed lung adenomas during the 12 months observation period and no other tumors were observed. Comparing the results of the test aniamls with the control shows no significant increase in the incidence of pulmonary tumors and skin tumors. Hence, benzoyl chloride may be considered as non-carcinogenic after repeated dose inhalation of vapourized benzoyl chloride.

 

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.