[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:

2007-05-02 to 2007-05-24

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:

2007

Report date:

2007

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:

adopted December 17, 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

April 29, 2004

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reaction products of DL-methionine and C18 unsaturated fatty acid chloride and isopropanol

Molecular formula:

not applicable (UVCB)

IUPAC Name:

Reaction products of DL-methionine and C18 unsaturated fatty acid chloride and isopropanol

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 07SK021
- Description: Liquid, dark brownish
- Expiration date of the lot/batch: n.a.
- Purity test date: 94%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5° C), light protected
- Solubility and stability of the test substance in the solvent/vehicle: unknown in PEG 300

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, CH-4414 Fuellinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11-12 weeks
- Weight at study initiation: at Day1 of treatment about 178- 208 g
- Fasting period before study: 18-19 hours
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 % (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Polyethylene glycol 300 (PEG 300)

Doses:

2000 mg/kg bw
dosing volume was 10 mL/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
Frequency of observations:
- Mortality/Viability and Clinical signs: during acclimatization and during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes

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 Deaths occurred during the study

Clinical signs:

other: A slightly ruffled fur was observed in all treated females at the 1 or 2 hours post-dose and persisted up to the 5-hour reading in one female and up to test day 2 in five females. Additionally, all females expressed a hunched posture at the 2-hour evaluat

Gross pathology:

No macroscopic findings were recorded at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of Dodicor V 5654 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight

Executive summary:

In order to evaluate the acute oral toxicity property of Dodicor V5654, an OECD 423 GLP conform study was performed in female Wistar rats.

Two groups of 3 rats were treated with Dodicor V 5654 by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle PEG 300 at a concentration of 0.2 g and administered at a dosing volume of 10 mL. The animals were examined for mortality, viability and clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. At end of observation period, all animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. A slightly ruffled fur was observed in all treated females at the 1 or 2 hours post-dose and persisted up to the 5-hour reading in one female and up to test day 2 in five females. Additionally, all females expressed a hunched posture at the 2-hour evaluation which persisted up to the 5-hour observation. Otherwise, no clinical signs were observed in any animal at any time at any observation. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.

Based on the results of this study, he median lethal dose of Dodicor V 5654 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.