Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

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other: Unpublished study report cited in a peer-reviewed publication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Diaethylcarbonat - Toxikologische Untersuchungen (unpublished report)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:
1970
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
Name:
Unnamed
Type:
Constituent
Test material form:
other: vapour
Details on test material:
not further specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals 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.