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Description of key information

Ethoxyamidin HCl is harmful after single oral exposure (LD50, rat: > 300 - < 500 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: 8-9 weeks
- Mean weight at study initiation: 219-237 g (males) or 163-174 g (females)
- Housing: in groups of 3 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): approx. 55 +/- 5
- Air changes (per hr): approx. 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
demineralized
Details on oral exposure:
- Application volume: 10 mL/kg bw

- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.
Doses:
200 mg/kg (males and females), 2000 mg/kg (females)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes
Statistics:
none
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 - < 500 mg/kg bw
Based on:
test mat.
Mortality:
The dose of 2000 mg/kg bw was lethal in females. All females died between 10 and 15 minutes after administration. All males and females of the dose group 200 mg/kg bw survived
Clinical signs:
At 200 mg/kg bw the motility and reactivity were decreased , the gait uncoordinated, breathing labored and salivation increased. The signs observed sarted directly after administration and lasted within 6 hours after administration.
Additionally to the signs described above, females of the dose group 2000 mg/kg bw showed tremor and abdominal position.
Body weight:
Body weight and body weight development of male and female rats were not affected by treatment.
Gross pathology:
In the female animals that died during the observation period a dark-red discoloration of liver was detected. The animals sacrificed at the end of the study showed no gross pathological findings.
Other findings:
none
Interpretation of results:
harmful
Remarks:
Migrated information
Executive summary:

The acute oral toxicity of Ethoxyamidin Hydrochloride was moderate with an LD50 value of > 300 < 500 mg/kg bw in rats according to OECD TG 423 (1996). All females died after oral ingestion of 2000 mg/kg bw. All males and females dosed with 200 mg/kg bw survived. Clinical signs were observed at 200 mg/kg bw and above in both genders. Body weight development was not affected at 200 mg/kg bw. In animals that died during the observation period a dark-red discoloration of the liver was detected.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of Ethoxyamidin Hydrochloride was moderate with an LD50 value of > 300 - < 500 mg/kg bw in rats according to OECD TG 423 (1996). All females died after oral ingestion of 2000 mg/kg bw. All males and females dosed with 200 mg/kg bw survived. Clinical signs were observed at 200 mg/kg bw and above in both genders. Body weight development was not affected at 200 mg/kg bw. In animals that died during the observation period a dark-red discoloration of the liver was detected.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for classification or non-classification

Based on the study results (oral LD50: > 300 - < 500 mg/kg bw ) a classification with R22 (harmful if swallowed) according to Directive 67/548/EEC or with Acute Toxicity Cat. 4 (H302:harmful if swallowed) according to Regulation (EC) No. 1272/2008 (CLP) is required.

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