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Diss Factsheets

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
Study period:
23 Sep. - 14 Oct. 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate
EC Number:
278-636-5
EC Name:
Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate
Cas Number:
77182-82-2
Molecular formula:
C5H12NO4P.H3N
IUPAC Name:
ammonium 2-amino-4-[hydroxy(methyl)phosphoryl]butanoate

Test animals

Species:
mouse
Strain:
NMRI
Remarks:
HoE: NMRKf (SPF71)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst
- Weight at study initiation: 22 - 26 g
- Fasting period before study: not specified
- Housing: group
- Diet: produced by Altromin GmbH, ad libitum
- Water: tap water; ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
315, 500, 800 mg/kg bw
No. of animals per sex per dose:
10 (females only)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing weekly, observations of intoxication and mortality rate performed
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 determined by probit analysis (Lindner/Weber method)
Confidence limits calculated: Fieller

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
416 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 345 - <= 498
Mortality:
1/10 animals / 315 mg/kg bw
8/10 animals / 500 mg/kg bw
10/10 animals / 800 mg/kg bw
Animals died within day 1 and 8 after treatment
Clinical signs:
Following symptoms were registered 24h after dosing: Ataxy, bizarre movements, squatting, abdominal position, clonic convulsions, convulsive jumping, rolling spasms, "Straub" phenomenon, increased salivation, irregular, jerky respiration, hyperactivity in the dosage group 315 mg/kg bw and benumbedness in the remaining groups.
Surviving animals recovered from day 2 after the treatment onwards whilst the animals that died later showed squatting, lateral posiion, bristled hair, poor general condition and in some instances barely perceptible respiratory movements which decreased respiratory rate until exitus

Body weight:
Before exitus marked decrease in body weight
Body weight gains of surviving animals were normal
Gross pathology:
Animals that died during the first days after the treatment showed translucent livers with hepatic marking at the edge in some instances and pulmonary plethora.
no abnormal findings for animals that died during the further course of the experiment or were killed after study termination

Applicant's summary and conclusion