Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Principles of method if other than guideline:
None
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)- 2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3- yl]diazenyl}benzenesulfonate
Cas Number:
106359-90-4
IUPAC Name:
Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)- 2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3- yl]diazenyl}benzenesulfonate
Test material form:
solid: particulate/powder
Details on test material:
None
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 8 weeks females: 10 weeks
- Weight at study initiation: males: 199 - 209 g females: 165 - 179 g
- Fasting: overnight
- Housing: Makrolon type-3 cages (size: 22 x 37.5 x 15 cm) with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard
- Water (e.g. ad libitum): Community tap water
- Acclimation period: One week under laboratory conditions, after veterinary examination. Only animals without any visual signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3 °C
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bidistilled
Details on oral exposure:
None
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 anmals per dose
Control animals:
yes
Details on study design:
None
Statistics:
The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Preliminary study:
None
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study period.
Clinical signs:
NO clinical signs were noted in the animals.
Body weight:
The body weight gain of the animals was not affected by the test article treatment throughout the entire study period.
Gross pathology:
No macroscopical organ findings were observed.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 40000/G in rats is greater than 2000 mg/kg bw.
Executive summary:

The test article FAT 40000/G was administered to groups of 5 male and 5 female rats by oral gavage, at single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of FAT 40000/G in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.