(1R*,6S*)-6-(ethoxycarbonyl)-N,N-dimethyl-6-phenylcyclohex-2-en-1-aminium monooxalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-(ethoxycarbonyl)-N,N-dimethyl-6-phenylcyclohex-2-en-1-aminium hydrogen oxalate

EC Number:

700-689-4

Cas Number:

41524-32-7

Molecular formula:

C17 H23 N O2 .C2 H2 O4

IUPAC Name:

6-(ethoxycarbonyl)-N,N-dimethyl-6-phenylcyclohex-2-en-1-aminium hydrogen oxalate

Details on test material:

- Name of test material (as cited in study report): trans-tilidin Oxalat, Erstabtrennung
- Test substance No: 10/0345-1
- Homogeneity: The test substance was homogenous by visual inspection.
- Analytical purity: > 99.5%
- Purity test date: > 99.5%
- batch No.: LV 8/10
- physical state/colour: solid / white
- Storage conditions: room temperature
- Storage stabilityl: The stability under storage conditions over the study period was guarenteed by the sponsor, and the sponsor
holds this responsibility.
- Other: pH-value: ca. 3 (undiluted test substance, moistened with water)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany.
- Age at study initiation: young adult animals (female animals approx. 9-11 weeks)
- Weight at study initiation: 190 - 198 g
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diet Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 6 females
2000 mg/kg bw: 3 females

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Mortality:

All animals of the 300 mg/kg bw dose group survived.
All animals of the 2000 mg/kg bw dose group died.

Clinical signs:

other: Clinical observation in the 2000 mg/kg bw test group revealed impaired and poor general state, dyspnoea, staggering, abdominal position, ataxia, twitching, chromodacryorrhea, exophthalmos, flat respiration, high stepping gait and salivation from hour 0 up

Gross pathology:

At necropsy two animals that died in the 2000 mg/kg bw test group showed dark red spotted discoloration in all lobes of the lung. Two animals showed gaseous stomach, filled with liquid content and two animals were found to have red discoloration of content in the small intestine and red discoloration of the small intestine. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this study the mean lethal dose of trans-tilidin-Oxalat, Erstabtrennung after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Based on the results of this study, the test substance trans-tilidin-Oxalat, Erstabtrennung has to be classified Acute Tox Cat 4 (Directive 1272/2008 of CLP) and R22 (67/548/EWG).