Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an acceptable BASF-test which in principle was similar to OECD 401; GLP was not compulsory at the time the study was conducted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Observation period was 7 days in place of 14.
Principles of method if other than guideline:
The study was conducted according to an acceptable BASF-test which in principle was similar to OECD guideline 401.
Five male and five female rats per test group were administered following doses of test item: 200, 2000, 3200, 4000, 5000 and 6400 mg/kg bw; the dose level 3200 mg/kg bw was tested twice. The test item was administered by gavage (single application) as aqueous solution; the application volume depending on the test dose ranged from 10 to 21 mL/kg bw.
Following treatment, the animals were regularly examined for mortality and clinical signs of toxicity over an observation period of 7 days; body weights were recorded at test starting. All rats that died during the observation period as well as the surviving rats, which were sacrificed at the end of the observation period, were subjected to necropsy.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butyldiäthanolamin
- Physical state: liquid
- Analytical purity: 100%

Test animals

Species:
rat
Strain:
other: US-Rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: young adult, no more data provided
- Weight at study initiation: males, 175 - 286 g; females, 150 - 210 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water with Traganth
Details on oral exposure:
- Concentration in vehicle (%): 2%, 20% and 30%
- Amount of vehicle: from 10 to 21 mL/kg bw
Doses:
Original values as given in study report: 200, 2000, 3200, 4000, 5000 and 6400 mm3/kg bw
Values converted into mg/kg bw (density: 0.970 g/cm3): ca. 190, 1900, 3100, 3900, 4850 and 6200 mg/kg bw
No. of animals per sex per dose:
10 animals /sex/dose group (dose level 3100 mg/kg bw was repeated).
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- The animals were observed for mortality twice each workday and once daily at weekends or public holidays;
- They were regularly observed for clinical symptoms of toxicity after following treatment and once daily thereafter.
- Body weight was determined before the start of the study only and served for the determination of the dosage.
- At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy;
- Animals that died during the observations period also were subjected to necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 800 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original value was given as 5000 mm3/kg bw
Mortality:
- At 190 mg/kg bw, none of the treated animals died.
- At 1900 mg/kg bw, none of the treated animals died.
- At 3100 mg/kg bw, in the first test, mortality was 30% (3/5 females died).
- At 3900 mg/kg bw, mortality was 10% (1/5 females died).
- At 4800 mg/kg bw, none of the treated animals died.
- At 6200 mg/kg bw, mortality reached 80% (4/5 males and 4/5 females).
- At 3100 mg/kg bw, in the second test, none of the treated animals died.

Almost all cases of death occurred within 48 hours following treatment.
Clinical signs:
- At the lowest dose levels of 190 and 1900 mg/kg bw, slight dyspnoea, prostration and piloerection were observed for 3 to 4 days following treatment; thereafter, the animals were free of symptoms.
- At a dose level of 3100 mg/kg bw, slight dyspnoea, prostration, piloerection, irregular breathing, unclean fur in the anal region and red incrusted noses were reported following treatment. The surviving animals recovered from day 3 post treatment.
- At the highest tested doses (3900, 4800 and 6200 mg/kg bw), irregular breathing, slight dyspnoea, agitation, slight salivation, high legged walking,and slight tremor when touched, were the main symptoms reported. Regarding the surviving animals, these showed partly incrusted eyes, piloerection, prostration and unclean fur; they recovered from day 5 to 6 post treatment.

Gross pathology:
Necropsy of some of the sacrificed animals revealed signs of bronchitis and bronchiectasis. In two cases, necropsy of animals that died revealed a poor nutritional status and diarrhea. No further abnormalities were noticed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was determined to be ca. 4800 mg/kg bw, for both male and female rats.
CLP: not classified
DSD: not classified
Executive summary:

Butyldiethanolamine was tested for acute oral toxicity by gavage in rats according to a BASF internal method. The test method is considered to be scientifically acceptable since similar to the OECD TG 401. Five rats per sex and group were treated by single application at following dose levels: ca. 190, 1900, 3100, 3900, 4850 and 6200 mg/kg bw. For the 3100 mg/kg bw dose level, the initial test was repeated. The animals were observed over a period of 7 days for mortalities and clinical symptoms of toxicity. At the end of the observation period, those animals that had survived the experiment were sacrificed for the purpose of necropsy. Those animals that died during the experiment also were subjected to gross pathological examination.

At 190 and 1900 mg/kg bw, none of the treated animals died. At 3100 mg/kg bw, in the first test, mortality was 30 % (3/5 females died), while in the second test at the same dose level, none of the treated animals died. At 3900 mg/kg bwm mortality was 10 % (1/5 females died), while at 4800 mg/kg bw, again, none of the treated animals died. At 6200 mg/kg bw, mortality reached 80 % (4/5 males and 4/5 females). Almost all cases of death occurred within 48 hours following treatment. Among clinical signs, slight dyspnoea, prostration, piloerection, irregular breathing, unclean fur in the anal region and red incrusted noses were observed at the dose levels of 190, 1900 and 3100 mg/kg bw. The surviving animals recovered from day 3 post treatment.

At the highest tested doses (3900, 4800 and 6200 mg/kg bw), irregular breathing, slight dyspnoea, agitation, slight salivation, high legged walking, and slight tremor when touched, were the main symptoms reported. Regarding the surviving animals, these showed partly incrusted eyes, piloerection, prostration and unclean fur; they recovered from day 5 to 6 post treatment. Necropsy of some of the sacrificed animals revealed signs of bronchitis and bronchiectasis. In two cases, necropsy of animals that died revealed a poor nutritional status and diarrhea. No further abnormalities were noticed.

LD50 was determined to be ca. 4800 mg/kg bw, for both male and female rats.