Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.