Registration Dossier
Registration Dossier
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EC number: 203-311-1 | CAS number: 105-58-8
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Unpublished study report cited in a peer-reviewed publication
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Diaethylcarbonat - Toxikologische Untersuchungen (unpublished report)
- Author:
- Bayer AG
- Year:
- 1 970
- Bibliographic source:
- BG Chemie (1994) Toxicological Evaluations 7. Potential Health Hazards of Existing Chemicals. Springer Verlag
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- see below
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Diethyl carbonate
- EC Number:
- 203-311-1
- EC Name:
- Diethyl carbonate
- Cas Number:
- 105-58-8
- Molecular formula:
- C5H10O3
- IUPAC Name:
- diethyl carbonate
- Test material form:
- other: vapour
- Details on test material:
- not further specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at study initiation: ca. 140 g
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- clean air
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- not further specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 7 hrs
- Frequency of treatment:
- five 7 hour periods per week over 4 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
18995 mg/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 m / 10 f
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- not further specified
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: yes (daily)
DETAILED CLINICAL OBSERVATIONS: yes (daily)
BODY WEIGHT: yes (weekly)
FOOD CONSUMPTION: no data
FOOD EFFICIENCY: no data
WATER CONSUMPTION: no data
OPHTHALMOSCOPIC EXAMINATION: no data
HAEMATOLOGY: yes (at termination)
CLINICAL CHEMISTRY: yes (at termination)
URINALYSIS: no data
NEUROBEHAVIOURAL EXAMINATION: no data - Sacrifice and pathology:
- internal organs were weighed and examined macroscopically
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 18 995 mg/m³ air
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a vapour inhalation study, groups of 10 male and 10 female rats were exposed to a concentration of 0 or 18995 mg/m3 on 7 hours/day on 5 days/week over 4 weeks. The treatment gave no indications for adverse effects concerning clinical symptoms or behaviour, body weight gain, blood composition or clinical-chemical parameters. At necropsy, the microscopic examination of internal organs showed no adverse effects and also organ weights were unchanged.
- Executive summary:
- In a vapour inhalation study, groups of 10 male and 10 female rats were exposed to a concentration of 0 or 18995 mg/m3 on 7 hours/day on 5 days/week over 4 weeks. The treatment gave no indications for adverse effects concerning clinical symptoms or behaviour, body weight gain, blood composition or clinical-chemical parameters. At necropsy, the microscopic examination of internal organs showed no adverse effects and also organ weights were unchanged.
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