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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
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable study, similar to OECD TG 401, without GLP, with minor restrictions in design and/or reporting but sufficiently reliable for assessment.
Justification for type of information:
The information is used to read across to Oenanthic ether.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Range finding test yielded four doses: 3.18; 3.96; 5.0; 6.3 ml/kg;
Appraisal of the safety of foods, drugs and cosmetics (FDA) rules applied
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Source: Winkelmann, Paderborn
Weight: ca. 140 g; fasting period before study:ND
Diet: Standard laboratory diet (Ssniff/Intermast)
Water: ad libitum
Acclimation period: 22°C ± 1°C, humidity of the air: 45- 55%, Light period: 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
After 16 hour starvation period, different doses were administered in groups of 10 rats each existing of 5 males and 5 females
Doses:
3.18; 3.96; 5.00; 6.30 ml/kg
No. of animals per sex per dose:
five
Control animals:
no
Details on study design:
Mortality and behaviour were observed for seven days. Animals that died were dissected to observe any changes in the physiological structures
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4.21 other: mL/kg bw (4500 mg/kg bw)
Based on:
test mat.
Remarks on result:
other: 24 hours and 7 days average following Litchfield and Wilcoxon with Gaussian approximation
Mortality:
Mortality:

24 hours           7 days
3.18 ml/kg      0/10                     0/10
3.96 ml/kg      4/10                     4/10
5.00 ml/kg      9/10                     9/10
6.30 ml/kg    10/10
Clinical signs:
In the doses applied the substance did not show any toxic symptoms other than apathy of the animals.
Body weight:
An increase of the average body weight from 135 to 156 g after 7 days was detected.
Gross pathology:
No abnormalities were found after necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The oral LD50 in rats was determined to be 4500 mg/kg bw.
Executive summary:

In an acute oral toxicity study conducted using a protocol similar to OECD guideline 401 (performed before GLP principles were implemented), undiluted test substance was administered via oral gavage to fasted Wistar rats (five males + five females/dose) at dose levels of 3.18, 3.96, 5 and 6.30 mL/kg. The animals were sluggish soon after administration. In the higher dose groups mortality was observed within 24 hours of dosing, while no mortality was observed after 7 days. Necropsy did not reveal any pathological effects. The LD50 was 4.21±1 mL/kg bw (4500 mg/kg bw) both for the 24 hour and 7 day observation period.