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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study 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:
no guideline followed
Principles of method if other than guideline:
Standardised study to determine the acute toxicity of the test item in mice after single i.p. application.
GLP compliance:
no
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:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 22 g (mean males), 23 g (mean females)
- Diet: Altromin R 1324 Haltungsdiaet fuer Ratten und Maeuse
No further information provided.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: 0.681 - 2.15% solution in aqua dest.
Details on exposure:
No data.
Doses:
68.1, 100, 147, 215 µL/kg bw (61, 89, 131, 192 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:
> 131 - < 192 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Corresponds to 147/215 µL/kg; the mg/kg was calculated on the density: d= 0.8917 g/cm³. 147 µL/kg: 1 female and 3 male animals died; 215 µL/kg: all animals died
Mortality:
68.1, 100 µL/kg bw: no animals died
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
215 µL/kg bw: all animals died
Clinical signs:
68.1 µL/kg bw: no abnormalities observed
100 µL/kg bw: irregular respiration and spastic gait
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
Body weight:
A body weight gain was observed until the end of the observation period in the following groups:
68.1 µg/mL: 35 g (mean males), 30 g (mean females)
100 µg/mL: 33.4 g (mean males), 31.6 g (mean females)
147 µg/mL: 32.5 g (mean males), 28.2 g (mean females)
Gross pathology:
No abnormalities observed.

Applicant's summary and conclusion

Conclusions:
LD50 of >-131 - <192 mg/kg bw was established in this study.
Executive summary:

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). 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 was 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.