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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from November 12, 2001 to January 15, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed according to test guideline in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, this study is used for read-across thus avoiding duplicate tests.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
FAT 41030/A
IUPAC Name:
FAT 41030/A
Test material form:
other: solid
Details on test material:
FAT 41'030/A

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test system Rat, HanBrl: Wist (SPF)
Rationale Reeognized by the international guidelines as a reeommended test system.
Source RCC Ud Bioteehnology and Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
Number of animals per group 3 males or 3 females
Total number of animals 3 males 3 females
Age when treated Males: 8-11 weeks Females: 10 weeks
Identification Unique bage card and corresponding color-coded spots on the tail.
Acclimatization Under laboratory conditions, after health examination Only animals without any visible signs of illness were used for the study.
HUSBANDRY
Room number E16
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 ± 3°C and for relative humidity between 30-70%. 12 hours fluoreseent light/12 hours dark, music during the light period.
Accommodation: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland) .
Diet: Pelleted standard Provimi Kliba 3433 rat maintenance diet (Provimi Kliba AG, CH-4303 KaiseraugstJ Switzerland) ad libitum. Batch no. 76/01 was used from the 28-NOV-2001 until the 10-DEC-2001, then batch no. 77/01 was used until the end of the study. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
Water: Community tap-water, from Itingen ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ud, Itingen.





Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: PEG 300
Details on oral exposure:
The animals received a single oral dose of the test item by gavage at 2000 mg/kg body weight after being fasted for 16 to 20 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with FA T 410301 A at 2000 mg/kg body weight, followed by an observation period of 14 days.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: All animals survived until the end of the study period. No clinical signs were evident during the course of the study.
Mortality:
All animals survived until the end of the study period.
Clinical signs:
No clinical signs were evident during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available data, LD50 was considered greater than 2000 mg/kg under the present conditions.
Executive summary:

This study was conducted according to OECD guideline 423 acute class toxicity complying with GLP conditions. One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with FA T 410301 A at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test 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. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

Therefore, it was concluded that the LD50 was considered greater than 2000 mg/kg.

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