[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-11-27 - 2009-01-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 423

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Gelb LD 6259 (No 08/0646-1)
- Physical state: solid/ sun yellow
- Analytical purity: 87.6 area% (230 nm) rather 89.1 area% (400 nm) (Method: HPLC)
- Lot/batch No.: 0817 VP 01
- Stability under test conditions: the stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility
- Storage condition of test material: room temperature
- Other: the test substance was homogeneous by visual inspection.

Test animals

Species:

rat

Strain:

other: Wistar / Crl:WI (Han)

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. 12 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Makrolon cage, type III; single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: acclimatization period at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for temperature
- Humidity (%): 20 – 80% for relative humidity
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Olive oil Ph.Eur.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: good homogeneity in Olive oil Ph.Eur.

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):
The test-substance preparation was produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer.
The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: by the request of the sponsor a starting dose of 2000 mg/kg body weight had been chosen in the first step with 3 female animals. Because no animal died at the first step, 2000 mg/kg body weight was administered to another group of 3 female animals in the second step.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per group (2 groups evaluated)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. 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. a check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.
- Necropsy of survivors performed: yes; necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2- inhalation in a chamber with increasing concentrations over time.
- Other examinations performed: clinical signs, organ weights

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animals died, no clinical signs

Mortality:

No mortality occurred.

Clinical signs:

No clinical findings were observed during clinical examination.

Body weight:

The mean body weights of the test groups increased normally throughout the study period (Table 1).

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Other findings:

not applicable

Any other information on results incl. tables

Table 1: Body weights changes

 

Individual body weight changes
Dose (mg/kg bw):	2000				2000
Administration:	1				2
Animal No.:	532	533	534	mw	567	568	569	mw
Body weight at study day (g):
0	204	205	188	199	180	177	194	184
7	216	217	198	210	191	195	213	200
14	223	227	203	218	200	207	217	208