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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted on 1981, 12th May; inhalation hazard test)
Deviations:
yes
Remarks:
(animals were observed for only 7 days, no details on animal husbandry, exposure period of up to 8 hours, concentration of test substance in air mixture was not verified analytically)
GLP compliance:
no
Test type:
other: Inhalation hazard test (IHT)

Test material

Constituent 1
Reference substance name:
Butylethanolamine
IUPAC Name:
Butylethanolamine
Details on test material:
- Name of test material (as cited in study report): Butylethanolamine
- Analytical purity: > 99%

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 230 g (mean)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20°C). 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8 h.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
24.69 mg/L
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Inhalation Hazard Test
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: no mortality was observed
Mortality:
No mortality was observed.
Clinical signs:
other: Mucous membrane irritation was observed.
Body weight:
The animals gained weight (250 g was the mean weight at the end of the study).
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
other: EU-GHS criteria not met (for Acute Toxicity: inhalation endpoint)
Conclusions:
No LC50 could be established. No animals died.
The Mucus membrane irritation observed in the treated animals points to the potential of N-Butylaminoethanol to cause respiratory irritation (please also refer to the Endpoint Summary Acute Toxicity).
Executive summary:

In an inhalation hazard test (IHT; BASF, 1977) 3 rats per sex were exposed to a saturated vapour atmosphere of the test substance for 8 hours. The mean nominal concentration of the test substance was 24.69 mg/L. No animal died. Mucous membrane irritation was observed and no abnormalities were seen at necropsy.