Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-02-13 till 2008-03-07
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40840/A TE
- Substance type: colouring dye
- Physical state: solid, dark red powder
- Analytical purity: approx. 78.9% org. part (NA-salt), MC: 37.7%, Oligomers: 19.2%
- Lot/batch No.: ROE 358 BOP 01/07
- Expiration date of the lot/batch: June 30, 2012
- Storage condition of test material: At room temperature at about 20°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC LTD, Laboratory Animal Serrvices
- Age at study initiation: 11-12 weeks
- Housing: in groups of three
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


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


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000mg/kg body weight
- Amount of vehicle (if gavage): 10mL/kg body weight
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 (2 groups: each 3 animals)
Control animals:
no
Details on study design:
- Duration of observation period following administration day: 14 days

- Frequency of observations and weighing:
Mortality/Viability: Daily during the acclimatization period, during the first 30 minutes and 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 days1 (prior to administration), 8 and 15
Clinical signs: Daily during the acclimatization period, during the first 30 minutes 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: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred during the study.
Clinical signs:
A slightly ruffled fur was recorded in two females 3 hours post-dose and persisted up to the 5-
hour reading. Soft feces were observed in all animals 5 hours after treatment. Discolorated
purple feces or purple/black feces were recorded in all animals 5 hours after treatment and
persisted up to test day 2.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
For Group 1 no macroscopic findings were recorded at necropsy. All animals of Group 2 were
found with an enlarged spleen at necropsy.

Any other information on results incl. tables

Body Weights

 Dose (mg/kg)  Group  Animal  Sex  Day 1  Day 8  Day 15
  2000  1  1  F  191.2 210.7   221.4
  2000  1   2  F  186.3  200.1  205.7
  2000  1  3   F 183.8  201.2   209.7
  2000  2 4    F  177.8 202.3   216.3
  2000  2  5    F 180.7   208.1  226.2
  2000 2   6   F  184.2  213.7  234.7

Macorscopic Findings

  Dose (mg/kg)  Group  Animal  Sex  Mode of death  Findings
  2000  1  1   F  S   No macroscopic findings
  2000  1  2   F  S   No macroscopic findings
  2000  1  3   F  S   No macroscopic findings
  2000  2  4   F  S   Enlarged spleen
  2000  2  5   F  S   Enlarged spleen
  2000  2  6   F  S   Enlarged spleen

S: scheduled necrospsy

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The median lethal dose of FAT 40840/A TE 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:

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with FAT 40840/A TE by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 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 were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. A slightly ruffled fur was recorded in two females 3 hours post-dose and persisted up to the 5- hour reading. Soft feces were observed in all animals 5 hours after treatment. Discolorated purple feces or purple/black feces were recorded in all animals 5 hours after treatment and persisted up to test day 2. The body weight of the animals was within the range commonly recorded for this strain and age. For Group 1 no macroscopic findings were recorded at necropsy. All animals of Group 2 were found with an enlarged spleen at necropsy.

The median lethal dose of FAT 40840/A TE 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