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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
end on 8 July 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: screening test, sufficiently described

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
screening test (few dose levels and animals used)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
EC Number:
273-992-8
EC Name:
Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
Cas Number:
69416-61-1
Molecular formula:
C13H15NO5.K
IUPAC Name:
potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
Details on test material:
- Name of test material (as cited in study report): FGH-KZ
- Substance type: monoconstituent substance
- Physical state: data not available
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Purity test date: data not available
- Lot/batch No.: 1109 A
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source, Age at study initiation, Weight at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available

ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available

IN-LIFE DATES: data not available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE: corn oil

MAXIMUM DOSE VOLUME APPLIED: dose volume of 10 ml/kg body weight
Doses:
2000, 1000 and 200 mg/kg bw
No. of animals per sex per dose:
1 male and 1 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical signs and mortality: at 0.10h, 2.30h and 3.40h after exposure and therafter each day for 15 days
> individual body weight: on days 1, 8 and 15
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
no mortality was observed
Clinical signs:
Piloerection and hunched posture were observed at all doses on days 3 and 4 after exposure. No other effects were observed.
Body weight:
No effect was observed
Gross pathology:
No effect was observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
oral LD50 (male, female) > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study (screening test), groups of Wistar rats (1/sex) were given a single oral dose of HPG-ds (potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate) in corn oil at doses of 200, 1000 and 2000 mg/kg bw and observed for 14 days.

 

Oral LD50 (male/female) > 2000 mg/kg (no mortality observed)

 

Piloerection and hunched posture were observed on days 3 and 4. No other clinical sign was observed. No abnormalities were observed on body weight or at necropsy.

 

HPG-ds (potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate) is of low toxicity based on the LD50 in males and females. It is not classified as dangerous according to EU criteria.

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