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Administrative data

Description of key information

Acute Toxicity:
- oral: LD50: 892 - 1310 mg/kg bw mg/kg bw (rat; BASF, 1977)
- dermal: LD0 of > 2000 mg/kg bw (Latven, 1977)
- inhalation: IHT - no mortality (rat, BASF XXVI/45, 1977)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(limited details on animal husbandry and the test substance)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 196 g (mean males), 166 g (mean females)
- Diet: Altromin R 1324 Haltungsdiaet fuer Ratten und Maeuse
No further information provided.
Route of administration:
oral: gavage
Vehicle:
other: 4.64 - 46.4% solution in aqua dest.
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: between 1.7 and 2.1 mL/kg bw
Doses:
464, 681, 1000, 1470, 2150, 3160, 4640 µL/kg bw (414, 607, 892, 1310, 1917, 2818, 4138 mg/kg bw - conversation in mg/kg is based on the density: d= 0.8917 g/cm³).
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: before the start and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 892 - < 1 310 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Corresponds to 1000/1470 µL/kg; the mg/kg was calculated on the density: d= 0.8917 g/cm³. 1000 µL/kg: 1 male and 2 female animals died 48 hours post exposure; 1470 µL/kg: all animals died
Mortality:
464, 681 µL/kg: no mortality observed
1000 µL/kg: 1 male and 1 female animal died 24 hours post exposure, 1 further female within 48 hours post application
1470, 2150, 3160, 4640 µL/kg: all animals died 24 hours post exposure
Clinical signs:
464 µL/kg bw: no abnormalities observed
681 µL/kg bw: gasping, spastic gait, ruffled fur and bad general state was observed in 2 animals 5 days post exposure
1000 µL/kg bw: gasping, apathy, staggering was observed after application until 2 days post exposure; spastic gait, ruffled fur and a bad general state on the following days
1470, 2150, 3160, 4640 µL/kg bw: irregular respiration, apathy staggering, diarrhoea containing blood and a bad general state was observed until the animals died
Body weight:
A body weight gain was observed until the end of the observation period in the following groups:
464 µL/kg bw: 255 g (mean males), 202 g (mean females)
681 µL/kg bw: 267 g (mean males), 203 g (mean females)
1000 µL/kg bw: 264 g (mean males), 206 g (mean females)
Gross pathology:
4640, 3160, 2150, 1470 µL/kg: dilatation of the heart and congestion hyperemia, anemic stomach with liquid content, atonic and reddened intestine
1000 µL/kg: dilatation of the heart and congestion hyperemia, anemic stomach with liquid content, intestine with diarrehoetic content
464, 681 µL/kg bw: no abnormalities observed
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 of 892-1310 mg/kg bw was determined in this study.
Executive summary:

In an acute oral toxicity study, male and female Sprague-Dawley rats were administered 414, 607, 892, 1310, 1917, 2818, 4138 mg/kg bw/day of the test substance. In the higher dose groups (1310 - 4138 mg/kg bw) irregular respiration, apathy, staggering, diarrhoea containing blood and a bad general state was observed until all animals died. In the other groups, except in the 414 mg/kg bw dose group, gasping, spastic gait, ruffled fur, bad general state was observed. In animals that died prior to study ending, dilatation of the heart and congestion hyperemia, anemic stomach with liquid content, atonic and reddened intestine was seen. The LD50 was set at 892 - 1310 mg/kg bw (BASF, 1977).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
892 mg/kg bw
Quality of whole database:
The study is well-documented and meets basic scientific principles.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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.
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)
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 230 g (mean)
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study is well-documented and meets basic scientific principles.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, brief report which meets basic scientific principles.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Each of six albino rabbits was treated dermally with 2000 mg/kg (2.24 mL/kg). Individual doses were applied to the hair-clipped skin of the trunk under a pre-fitted occluding sleeve on each animal. The sleeves were removed 24 hours later and the animals were observed for 7 days.
GLP compliance:
no
Test type:
other: 6 albino rabbits were treated dermally with 2000 mg/kg
Limit test:
yes
Species:
rabbit
Strain:
other: the only information given: albino rabbits
Sex:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: a pre-fitted occluding sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
2000 mg/kg (=2.24 mL/kg bw)
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs, body weight
Sex:
not specified
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: each of the treated animals remained asymptomatic and gained body weight during the observation period.
Mortality:
no mortality
Clinical signs:
the animals remained asymptomatic
Body weight:
the animals gained body weight during the observation period
Gross pathology:
no data
Other findings:
no other findings reported
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects were observed in treated animals after 24-hour dermal application of 2000 mg/kg bw of test material.
Executive summary:

Each of six albino rabbits was treated dermally with 2000 mg/kg (2.24 mL/kg). Individual doses were applied to the hair-clipped skin of the trunk unter a pre-fitted occluding sleeve on each animal. The sleeves were removed 24 hours later and the animals were observed for 7 days. Each of the treated animals remained asymptomatic and gained body weight during the observation period. Based on the results of the study, The LD0 of the test material is greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study report is well-documented and meets basic scientific principles.

Additional information

Acute oral toxicity:

In an acute oral toxicity study, male and female Sprague-Dawley rats were administered 414, 607, 892, 1310, 1917, 2818, 4138 mg/kg bw/day of the test substance (BASF, 1977; Report No. XXVI/45). In the higher dose groups (1310 - 4138 mg/kg bw) irregular respiration, apathy, staggering, containing blood and a bad general state was observed until all animals died. In the other groups, except in the 414 mg/kg bw dose group, gasping, spastic gait, ruffled fur, bad general state was observed. In animals that died prior to study ending, dilatation of the heart and congestion hyperemia, anemic stomach with liquid content, atonic and reddened intestine was seen. The LD50 was set at 892 - 1310 mg/kg bw.

Acute dermal toxicity:

Each of six albino rabbits was treated dermally with 2000 mg/kg (2.24 mL/kg) of butylethanolamine (Latven, 1977). Individual doses were applied to the hair-clipped skin of the trunk under a pre-fitted occluding sleeve on each animal. The sleeves were removed 24 hours later and the animals were observed for 7 days. Each of the treated animals remained asymptomatic and gained body weight during the observation period. Based on the results of the study, the LD0 of the test material is greater than 2000 mg/kg bw.

Acute inhalative toxicity:

In an inhalation hazard test (IHT; BASF, 1977; Report No. XXVI/45) 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.

Acute toxicity: other routes: i.p.

Butylethanolamine was administered intraperitoneally to 5 NMRI mice per sex and dose at dose levels of 68.1, 100, 147 and 215 µL/kg bw (61, 89, 131 and 192 mg/kg bw - conversation in mg/kg is based on the density: d= 0.8917 g/cm³) (BASF, 1977; Report No. XXVI/45). The dilutions of the test substance were prepared in water as 0.681 - 2.15 %. The animals were observed for signs of toxicity during 14 days. No animals died at 68.1, 100 µL/kg bw. At 147 µL/kg bw, 1 male and 1 female animal died 48 hours post application; 1 female and 3 male animals died until the end of the observation period. At 215 µL/kg bw: all animals died. Body weights of surviving animals decreased. No clinical signs were observed in 68.1 µL/kg bw dose group. At dose level of 100 µL/kg bw, irregular respiration and spastic gait were noted. At 147 µL/kg bw, irregular respiration, spastic gait, apathy were observed immediately after application until the 5th day post exposure; ruffled fur and tremors on several days. LD50 of > 131 - < 192 mg/kg bw was established in the study.


Justification for selection of acute toxicity – oral endpoint
The most reliable study available

Justification for selection of acute toxicity – inhalation endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data (LD50 of 892 -1310 mg/kg bw), classification for acute oral toxicity (Cat. 4) is warranted.

In the IHT, mucous membrane irritation was observed in treated animals by inhalation during 8 hours (BASF, 1977). In analogy to a structurally similar substance DBEA (CAS 102 -81 -8), butylethanolamine meets the criteria for classification and labelling for STOT-SE (Cat 3; H335, May cause respiratory irritation) according to Regulation (EC) No.1272/2008.