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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Details on test item, housing conditions are missing
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[2-(4-phenoxyphenoxy)ethyl]propanamide
EC Number:
600-606-0
Cas Number:
104825-66-3
Molecular formula:
C17H19NO3
IUPAC Name:
N-[2-(4-phenoxyphenoxy)ethyl]propanamide
Test material form:
solid
Details on test material:
Appearance: brown-beige solid
Molecular weight: 286
Melting point: 110 °C
Not soluble in water, PEG400 and oilve oil
Specific details on test material used for the study:
Appearance: brown-beige solid
Test item name (as cited in the report): para phenoxy phenoxy ethyl propionamid
Molecular weight: 286
Melting point: 110 °C
Not soluble in water, PEG400 and oilve oil

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Initial weight: 210 ± 10 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Remarks:
20% (w/v)
Details on oral exposure:
The test item was not soluble in water, PEG400 and oilve oil. It was diluted in DMSO at 20 % (200 mg/mL)
Doses:
0.5, 1, 2, 3, 3.5, and 4 g/kg bw
No. of animals per sex per dose:
10/dose
Control animals:
no
Details on study design:
Animals were fasted at 5 PM the day before administration and they are fed again 3 h after administration.
Administration occured at 10 AM.
Animals were observed daily for 14 days.
Survivals are weighed the 7th day after administration.
Macroscopic examination was performed at sacrifice or in prematurely dead animals.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 750 mg/kg bw
Based on:
test mat.
Mortality:
1/10 at 3 g/kg bw (on Day 1), 3/10 at 3.5 g/kg bw (on Day 2) and 7/10 (on Day 2) at 4 g/kg bw
Clinical signs:
other: No data
Gross pathology:
No findings
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, a LD50 of 3750 mg/kg bw was found in male Wistar rats with test item in DMSO (20 % (w/v))
Executive summary:

Groups of 10 fasted male Wistar rats were administered para phenoxy phenoxy ethyl propionamid in DMSO (20% (w/v)) at 0.5, 1, 2, 3, 3.5 and 4 g/kg bw by gavage. They were observed for 14 days and weighed on Day 7. 1 rat/10 at 3 g/kg bw (on Day 1), 3 rats/10 at 3.5 g/kg bw (on Day 2) and 7 rats/10 (on Day 2) at 4 g/kg bw died. No macroscopic findings were recorded in dead animals or survivals. Under the test conditions, a LD50 of 3750 mg/kg bw was determined. Therefore the substance is not classified according to CLP regulation and is classified category 5 (H303) according to GHS.