[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:

Experiment start date - 21 December 2004; Experiment completion date - 13 January 2005; Study completion date - 02 February 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

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:

FAT40819/A TE

IUPAC Name:

FAT40819/A TE

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40819/A
- Purity: Approx. 77%
- Lot/batch No.: Red ROE 420 BOP 01/04
- Expiration date: 2 November 2009
- Stability of test item: stable under storage conditions
- Stability of test item dilution: Stable in polyethylene glycol for at least 7 days at room temperature.
- Storage conditions: At room temperature (range of 20 ± 5 °C), light and moisture (dessiccator) protected.

Specific details on test material used for the study:

Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.

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 Füllinsdorf / Switzerland
- Age when treated: 12 weeks
- Fasting period before study: approximately 18 to 19 hours
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 42/04 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland), ad libitum.
- Water: Community tap water from Füllinsdorf ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

APPLICATION VOLUME: 10 mL/kg body weight.

Doses:

2000 mg/kg bw

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:
Mortality/Viability: Daily during the acclimatization period, at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: Macroscopic examinations were performed. No organs or tissues were retained.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

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: Slightly ruffled fur with hunched posture was noted in all animals of the first treated group at the 2- and 3-hour reading. Red soft faeces were present in the cage between the 1- and 5-hour reading. Red discoloration of the softwood bedding was also note

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the observations the median lethal dose of the test substance is greater than 2000 mg/kg body weight

Executive summary:

In a GLP-compliant oral toxicity study, performed according to OECD guideline 423, Wistar rats (2 groups of 3 females) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period. All animals survived until the end of the study period and no changes in body weights and macroscopic findings were observed. The only clinical signs observed, were slightly ruffled fur with hunched posture in all animals of the first treated group at the 2- and 3-hour reading and slightly ruffled fur in two animals of the second treated group from the 1- to 3-hour reading which persisted in one animal up to the 5-hour reading. Hunched posture was noted in the same animals at the 2- and 3-hour reading. Red soft faeces were present in the cage between the 1- and 5-hour reading of the first treated group and were also noted on test day 2. Red discoloration of the softwood bedding was also noted between the 2-hour reading and test day 2. Red faeces as well as red discoloration of the softwood bedding was also noted in the cage of the second treated group at the 1-hour reading and red soft faeces with red discoloration of the softwood bedding was noted up to test day 2. Slight sedation was noted in one animal from the 1- to the 3-hour reading and slight ataxia was noted in the same animal from the 2- to the 5-hour reading of the second treated group. Based on the observations, the median lethal dose of the test substance in female rats observed for a period of 14 days was greater than 2000 mg/kg bw.