Registration Dossier
Registration Dossier
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EC number: 203-797-5 | CAS number: 110-73-6
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP proprietary study, predates OECD guideline, but scientifically fully acceptable and well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Methods of HF Smyth et al An.Ind.Hyg.ASS.J. 23. 95-107 (1962). Rats were exposed to a saturated vapour concentration atmosphere at 2.17 mg/L for seven hours and respiratory tract irritation and mortality monitored. BASF-Test: standard method for acute inhalation toxicity with rats exposed to a saturated atmosphere for 8 h.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylethanolamine
- IUPAC Name:
- 2-ethylethanolamine
- Reference substance name:
- 2-ethylaminoethanol
- EC Number:
- 203-797-5
- EC Name:
- 2-ethylaminoethanol
- Cas Number:
- 110-73-6
- Molecular formula:
- C4H11NO
- IUPAC Name:
- 2-ethylaminoethanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report):ethylethanolamine
- Physical state: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no information
- Age at study initiation:no information
- Weight at study initiation: males approximately *** g (group mean) and females *** g (group mean)
- Fasting period before study: not applicable for inhalation route
IN-LIFE DATES: From: February 1978 To: March 1978
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Details on inhalation exposure:
- Rats were exposed to a saturated vapour concentration atmosphere of 2.17 mg/L for seven hours and respiratory tract irritation and mortality monitored.
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Water bath, 200 L air/h, 20°C, saturated atmosphere
The vapours were generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 7 h
- Concentrations:
- 2.16 mg/L saturated vapour concentration - saturated vapour concentration
- No. of animals per sex per dose:
- a group of 12 rats were exposed, no information on sex ratio
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology, body weight (at start of study) - Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- other: maximum achievable dose toleration over an extended exposure period
- Effect level:
- > 2.17 mg/L air
- Based on:
- other: exposure to saturated vapour concentration over a 7 h period
- Exp. duration:
- 7 h
- Remarks on result:
- other: No mortality following a 7-hour exposure to a saturated vapour concentration
- Mortality:
- No mortality among twelve rats exposed to 2.17 mg/L for 7 hours
- Clinical signs:
- other: nasal discharge/bloody nose intermittent breathing mild corrosion of the nose unkempt fur unsteady gait
- Body weight:
- No data
- Gross pathology:
- No information
- Other findings:
- No information
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No deaths occurred in a group of twelve rats exposed by inhalation to the saturated vapour concentration of 2.17 mg/L. The animals were exposed for a period of seven hours without serious adverse effect.
- Executive summary:
Rats were exposed to a saturated vapour concentration atmosphere at 2.17 mg/L for seven hours and respiratory tract irritation and mortality monitored. No deaths occurred in a group of twelve rats exposed by inhalation to the saturated vapour concentration of 2.17 mg/L. The animals were exposed for a period of seven hours without serious adverse effect. No deaths occurred at the saturated vapour concentration: the acute LC50 is therefore >2.17 mg/L
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