[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

Cas Number:

914918-26-6

Molecular formula:

C46H40O16

IUPAC Name:

[3-methoxycarbonyl-4-[6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carbonyl]oxy-phenyl] 6-(4-prop-2-enoyloxybutoxycarbonyloxy)naphthalene-2-carboxylate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: RCC Ltd Laboratory Animal Services, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland- Age at study initiation: 8-12 weeks- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum- Housing: singly- Diet: ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 3- Humidity (%): 30-70- Air changes (per hr): 10 - Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 %

Details on oral exposure:

VEHICLE- Concentration in vehicle: 20 g/100 mL- Amount of vehicle: 10 mL/ kg bw- Justification for choice of vehicle: A good homogeneity in water could not be guaranteed, because the test item preparation was a suspension. Therefore a 0.5 % solution of CMC in deionized water was applicable. MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bwCLASS METHOD- Rationale for the selection of the starting dose: requested by the sponsor, no acute toxiicty expected up to 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.- Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals; these records are maintained with the raw data.- Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.- Pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing by CO2-inhalation.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No clinical signs were observed during clinical examination.

Body weight:

The mean body weight increased within the normal range throughout the study period.

Gross pathology:

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:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU