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Toxicological information

Acute Toxicity: oral

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Administrative data

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.

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 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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylaethanolamin
- Analytical purity: > 99 %

Test animals

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.

Administration / exposure

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

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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).