Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Substance concentration was not measured.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five animals per sex were exposed to substantially saturated vapor for 6 hours using a static exposure system.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monoethanolamine
- no further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: none
- Diet: commercial appropriate diet ad libitum
- Water: municipal water ad libitum

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The vapor was produced by enclosing approximately 100 g of the test material in a sealed 100 to 151 liter animal chamber for approximately 18 hours under static conditions. A mixing fan periodically agitated the chamber atmosphere to aid in distribution of the vapour. Oxygen was added, as needed to maintain a chamber oxygen content of approximately 20%. The temperature was maintained at 25 degrees C.


Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
ca. 1.3 mg/L air
Exp. duration:
6 h
Remarks on result:
other: Value derived from theoretical saturated vapor concentrations of monoethanolamine at room temperature and was not measured during the experiment.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.3 mg/L air
Exp. duration:
6 h
Mortality:
There were no deaths noted for males or females exposed to the highest concentration achievable for 6 hours.
Clinical signs:
There were no signs of toxicity noted for males or females exposed to the highest concentration achievable for 6 hours.
Body weight:
Nothing abnormal reported.
Gross pathology:
The necropsy findings noted nothing remarkable in males or females.

Any other information on results incl. tables

The theoretical saturated vapor concentration of monoethanolamine at room temperature is 520 ppm (1.3 mg/l). The LC50 is greater than 520 ppm (Reviews of Environmental Contamination and Toxicology, Vol. 149, 1997.)

Applicant's summary and conclusion