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: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Substance concentration was not measured.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
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: Monoethanolamine (2-Aminoethanol)

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 vapour was produced by enclosing approximately 100 g of the test material in a sealed 100-150 L 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 °C.


Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: days 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
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: This value was 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
Based on:
test mat.
Exp. duration:
6 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.487 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Please refer to section "Any other information on results incl. tables" below.
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:
No abnormalities were reported.
Gross pathology:
The necropsy findings revealed nothing remarkable in males or females.

Any other information on results incl. tables

The theoretical saturated vapour 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, 1997). Using modified Haber's law with n = 3 as a default value in accordance with Chapter R.7a (ECHA, 2012) for extrapolation from longer to shorter exposure duration, the LC50(4 hours) of 2 -Aminoethanol is calculated to be >1.487 mg/L.

References:

ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance, R7.4.4.1, p 258. ECHA-12 -G-11 -EN.

Reviews of Environmental Contamination and Toxicology (1997). Vol 149.

Applicant's summary and conclusion