Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data taken from IUCLID4 report with no information on methods or GLP status.

Data source

Reference
Reference Type:
review article or handbook
Title:
Characteristics of the General Toxic, Gonadatropic, and Mutagenic Effects of 1,3-chlorobromopropane
Author:
Eytingon, A.I.
Year:
1971
Bibliographic source:
Toksikologiya Novykh Promyshlennykh Khimicheskikh Veshchestv, No. 12, p. 93-100

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No guideline mentioned in data source.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-3-chloropropane
EC Number:
203-697-1
EC Name:
1-bromo-3-chloropropane
Cas Number:
109-70-6
Molecular formula:
C3H6BrCl
IUPAC Name:
1-bromo-3-chloropropane

Test animals

Species:
rat

Administration / exposure

Route of administration:
other: oral and inhalation
Duration of treatment / exposure:
28 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0,045 & 0,0054 mg/liter
No. of animals per sex per dose:
6 animals per group

Examinations

Observations and examinations performed and frequency:
Various effects were seen from the high concentration : increased summation threshold index, decreased ability to eliminate sulfobromophthalein from the blood, and increased liver weight coefficients.
Sacrifice and pathology:
Histologically, liver changes included moderate albuminoid and fatty degeneration of the parenchyma and focal proliferation of the interstitial tissue cells. Few effects were seen as a result of the lower concentration ; histological effects were mild.
Other examinations:
After a one-month recovery period, the residual pathological processes were hardly noticeable, and were of a proliferative nature. Anaphase analysis of bone marrow cells showed higher number of chromosome aberrations in animals exposed to 0,45 mg/liter than in the control animals. Changes in germinal epithelium and a tendency towards reduction in testicular weight coefficient and spermatozoa motility time were noted.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
There were no deaths in animals by the 24th day when animals had received 9 x LD50. During the next 4 days, animals tolerated daily doses nearly as high as the LD50.
Mortality:
mortality observed, treatment-related
Description (incidence):
There were no deaths in animals by the 24th day when animals had received 9 x LD50. During the next 4 days, animals tolerated daily doses nearly as high as the LD50.
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
decreased ability to eliminate sulfobromophthalein from the blood
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
increased liver weight coefficients
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
increased summation threshold index
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
liver changes included moderate albuminoid and fatty degeneration of the parenchyma
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
focal proliferation of the interstitial tissue cells.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The observations made on bone marrow cells reavealed chromosome aberrations in animals exposed to 0,45 mg/liter of the test substance : this tends to confirm a mutagenic potential of 1-bromo-3-chloropropane (see abstract in chapter 7.6).