Registration Dossier
Registration Dossier
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EC number: 203-870-1 | CAS number: 111-44-4
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Title:
- Toxicological profile for bis(2-chloroethyl) ether
- Author:
- USEPA
- Year:
- 1 989
- Bibliographic source:
- Agency for Toxic Substances and Disease Registry U.S. Public Health Service
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study report from Dow chemical (1958). Exposure to a fixed dose 7hr/day, 5dys/week for 130 days. No access to the full study report.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Bis(2-chloroethyl) ether
- EC Number:
- 203-870-1
- EC Name:
- Bis(2-chloroethyl) ether
- Cas Number:
- 111-44-4
- Molecular formula:
- C4H8Cl2O
- IUPAC Name:
- 1-chloro-2-(2-chloroethoxy)ethane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- Name (as cited): Bis(2-chloroethyl) ether
- Purity: not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 130 days
- Frequency of treatment:
- 7h/day; 5 days/week
Doses / concentrations
- Dose / conc.:
- 69 ppm
- Remarks:
- equivalent to 0.43 mg/L
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
HAEMATOLOGY: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Organ weight (lungs)
HISTOPATHOLOGY: Yes
- Lungs; Kidneys; Liver; Heart
Results and discussion
Results of examinations
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced body weight was observed.
- Haematological findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No significant changes in lung/body weight ratios.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histological changes in lungs, heart, liver and kidneys.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 69 ppm
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- mortality
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 69 ppm
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEC
- Effect level:
- 69 ppm
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- haematology
- Dose descriptor:
- NOAEC
- Effect level:
- 69 ppm
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In the conditions of this test, following repeated exposure via the inhalation route for 130 days, the LOAEC of Bis(2-chloroethyl) ether in rats is 69 ppm.
- Executive summary:
In this review on the toxicology of Bis(2-chloroethyl) ether, the author cites an unpublished study from Dow Chemical (1958), where rats were exposed for 130 days to the substance (concentration: 69 ppm; 7h/days; 5 days/week). The publication does not detail the result obtained from this study. The significance of the findings is questionable as only one test concentration was studied and the number of test animals is not specified. However, it has been subjected to the formal review process of U.S. EPA and it is thus judged acceptable for the assessment of the substance.
Regarding the results of this study, it is stated that the following parameters were examined: mortality, body weight, histopathology of main organs (including heart, lungs, kidneys, liver), haematology, and neurological parameters (unspecified). Exposure to the substance did not result in significant changes in lung/body weight ratios, and did not lead to histological changes in lungs. The only finding observed following the 130 days exposure period was a decrease in body weight. Accordingly, based on this study the LOAEC of Bis(2-chloroethyl) ether in rats is 69 ppm.
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