Registration Dossier
Registration Dossier
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EC number: 208-816-0 | CAS number: 542-52-9
Endpoint summary
Administrative data
Description of key information
LD50 (rat) > 2000mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- March, 1996
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Sept., 1996
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- August 1998
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B323
- Purity test date: July 4, 2001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: confirmed for at least 4h
OTHER SPECIFICS: Colorless liquid - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: males: 8-12 weeks, females: 14-18 weeks
- Weight at study initiation: males: 224, 231, 232g, females: 197, 200, 204g
- Fasting period before study: feed was withdrawn for at least 16h before administration. Water was available ad lib.
- Housing: single in stainless steel wire mesh cages, type DK-III
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40g/100g
- Justification for choice of vehicle: solubility
MAXIMUM DOSE VOLUME APPLIED: 5ml/kg - Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday thereafter. Body weights were determined weekly. A check for mortality was performed twice each workday and once on weekends and public holidays.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other:
- Remarks:
- no mortality occured
- Mortality:
- none
- Clinical signs:
- other: none in males Females showed impaired general state, dyspnoea and staggering starting 4h after administration and ending 1-2 hours later.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
A single dose of 2,000 mg/kg body weight of Dibutylcarbonate in olive oil was given to three male and three female rats by gavage. No mortality occurred. Clinical signs and findings in the female animals comprised impaired general state, dyspnoea and staggering. Findings were observed from hour 4 until including hour 5 after administration. No clinical signs and findings were observed in the male animals. The mean body weights of both sexes increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period. Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2,000 mg/kg body weight for male and female rats.
Justification for classification or non-classification
No mortality occured after oral exposure to 2000mg/kg of the registered substance. Consequently, no classification is required according to EU GHS, Regulation (EC) 1272/2008.
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